openFDA website screenshot

openFDA

openFDA is the U.S. Food and Drug Administration's public data platform, providing Elasticsearch-backed REST APIs serving FDA-administered data on drugs, medical devices, foods, animal and veterinary products, and tobacco. Twenty-two endpoints under a single api.fda.gov base URL expose adverse event reports (FAERS, MAUDE, CAERS), recall enforcement reports, Structured Product Labeling, the National Drug Code Directory, Drugs@FDA approvals, drug shortages, device classification, 510(k) and PMA submissions, Unique Device Identifier records, registration and listing, NSDE drug data, FDA substance harmonization, and historical FDA documents. All endpoints share a Lucene-style search, sort, count, limit, and skip parameter surface, are released under CC0 Public Domain, and operate under a free api.data.gov key that lifts daily quotas to 120,000 requests.

openFDA publishes 6 APIs on the APIs.io network, including Animal & Veterinary API, Device API, Drug API, and 3 more. Tagged areas include Government, Healthcare, Drug, Device, and Food.

The openFDA catalog on APIs.io includes 1 JSON-LD context and 2 Spectral governance rulesets.

openFDA’s developer surface includes authentication, developer portal, documentation, signup flow, getting-started guide, API reference, changelog, and 24 more developer resources.

49.6/100 developing ▬ flat Agent 36/100 agent ready Full breakdown ↓
scored 2026-08-05 · rubric v0.9.1
AccessSelf serve
6 APIs 12 Features 7 Use Cases
GovernmentHealthcareDrugDeviceFoodAnimal & VeterinaryTobaccoPublic DataOpen DataAdverse EventsRecallsRegulatory

Kin Score

Kin Score Kin Score How this is scored →
scored 2026-08-05 · rubric v0.9.1
Composite quality — 49.6/100 · developing
Contract Quality 15.5 / 25
Developer Ergonomics 10.0 / 20
Commercial Clarity 4.2 / 20
Operational Transparency 4.8 / 13
Governance 8.3 / 12
Discoverability 7.4 / 10
Agent readiness — 36/100 · agent ready
Machine-Readable Contract 18 / 18
Agentic Access Contract 10 / 10
MCP Server 0 / 12
Machine-Readable Auth 10 / 10
Idempotency 0 / 9
Stable Error Semantics 8 / 8
Request/Response Examples 7 / 7
Rate-Limit Signaling 7 / 7
Typed Event Surface 0 / 6
Agent Skills 0 / 5
Well-Known Catalog 0 / 4
Consent & Bot Identity 0 / 3
A2A Agent Card 0 / 8
Dry-Run / Simulate Mode 0 / 4
Improve this rating by publishing the missing artifacts — every area above can be raised, and the full rubric is at apis.io/rating/. This rating is computed from github.com/api-evangelist/openfda: open an issue to ask a question, or submit a pull request to add artifacts. Want it done for you? Prioritized profiling — $2,500 →

APIs 6

Individual APIs this provider publishes, each with its own machine-readable definition.

openFDA Animal & Veterinary API

Adverse events involving animal and veterinary products.

openFDA Device API

Device-related endpoints (adverse events, classifications, recalls, 510(k), PMA, UDI).

openFDA Drug API

Drug-related endpoints (adverse events, labeling, recalls, NDC).

openFDA Food API

Food-related endpoints (enforcement reports, adverse events).

openFDA Other API

Cross-cutting datasets (NSDE, substance, harmonized).

openFDA Tobacco API

Tobacco product problem reports.

Open Collections 1

Open, tool-agnostic API collections (OpenAPI-derived and Bruno).

openFDA API

OPEN COLLECTION

Rate Limits 1

Documented rate limits and quota policies.

Openfda Rate Limits

0 limits

RATE LIMITS

Features 12

Notable capabilities this provider offers.

Six product-domain APIs (drug, device, food, animal & veterinary, tobacco, other) under a single api.fda.gov base URL
Twenty-two Lucene-queryable JSON endpoints sharing search, sort, count, limit, and skip parameters
Aggregation via the count parameter returns frequency histograms on any field without retrieving documents
Bulk download of every dataset as JSON archives partitioned for resumable transfer
Optional free api.data.gov API key lifts the per-IP daily quota from 1,000 to 120,000 requests
Per-minute ceiling of 240 requests/min applies uniformly to anonymous and keyed callers
Pagination capped at skip=25,000 with limit=1,000; deeper traversal requires bulk downloads
All endpoints are CC0 Public Domain — no attribution required for commercial or research reuse
Harmonized openfda block on most documents links each record back to NDC, UNII, SPL Set ID, and other identifiers
HTTPS-only with HTTP Basic or query-parameter key authentication
Public status page and email list for outage and breaking-change notifications
Active developer community via the openFDA GitHub organization and community forum

Scroll for all 12

Semantic Vocabularies 1

JSON-LD contexts and semantic vocabularies used across these APIs.

Openfda Context

17 classes · 5 properties

JSON-LD

Spectral Rules 2

Spectral governance rulesets for linting and validating these APIs.

openFDA API Rules

5 rules · 4 warnings 1 info

SPECTRAL

openFDA API Rules

0 rules ·

SPECTRAL

JSON Schema 1

Standalone JSON Schema definitions for this provider's data models.

openFDA Search Response

2 properties

JSON SCHEMA

Examples 1

Example request and response payloads for these APIs.

Security Posture 2

Authentication, domain security, vulnerability disclosure, and trust-center signals.

Openfda Authentication

apiKey · 1 scheme

SECURITY

Openfda Domain Security

TLSv1.3 · HSTS · DNSSEC · DMARC

SECURITY

Agentic Access 1

Recommended x-agentic-access execution contracts for AI agents.

Openfda Agentic Access

22 operations

22 operations · 0 acting

AGENTIC

Use Cases 7

What developers build with this provider.

Adverse Event Surveillance

Mine FAERS, MAUDE, CAERS, and animal/veterinary adverse event reports for safety signals across drugs, devices, foods, and animal products.

Recall Monitoring

Subscribe to drug, device, and food recall enforcement reports and surface them in clinical, retail, or supply-chain dashboards.

Drug Labeling Apps

Embed authoritative indications, dosage, warnings, and ingredient sections from Structured Product Labeling into consumer or clinical applications.

Regulatory Intelligence

Track 510(k) clearances, PMA approvals, and Drugs@FDA submissions to monitor competitor and pipeline activity.

Identifier Resolution

Look up NDC, UDI, UNII, and SPL Set IDs across product domains to power claims, EHR, and supply-chain integrations.

Public-Health Research

Academic and journalistic investigation of adverse outcomes, recall patterns, and regulatory enforcement using CC0 public data.

Supply-Chain Risk

Cross-reference drug shortage status, recall actions, and registration listings to detect upstream supply disruptions.

Scroll for all 7

Integrations 6

Pre-built integrations with other platforms and tools.

api.data.gov

Federal API gateway that issues and enforces the openFDA API key, applying rate limits and quotas.

data.gov

openFDA datasets are cataloged in the federal open-data portal as DCAT-compliant resources.

NIH RxNorm

NDC and Drugs@FDA records are commonly joined with NIH RxNorm to align brand, generic, and ingredient terminology.

NLM DailyMed

SPL drug labeling in openFDA mirrors NLM DailyMed, the authoritative SPL repository.

GUDID (Global UDI Database)

openFDA device UDI records derive from FDA's Global Unique Device Identification Database.

FAERS Public Dashboard

openFDA drug adverse event endpoint surfaces the same FAERS data exposed in FDA's public dashboard.

Solutions 4

Packaged solutions this provider offers.

Pharmacovigilance

Continuously ingest drug, device, and food adverse events for safety signal detection.

Recall and Withdrawal Alerting

Power weekly recall enforcement notification workflows across drug, device, and food domains.

Regulatory Filings Intelligence

Aggregate 510(k), PMA, and Drugs@FDA submissions for competitive analysis and pipeline tracking.

Clinical Decision Support References

Surface FDA labeling content as a reference layer (explicitly not for clinical decision-making per openFDA terms).

Resources

Get Started 3

Portal, sign-up, and the first successful call

Documentation 7

Reference material describing how the API behaves

Scroll for all 7

Agent Surfaces 1

MCP servers, agent skills, and machine-readable catalogs

Design & Contract 5

Pagination, idempotency, versioning, errors, and events

Build 4

SDKs, sample code, and the tooling you integrate with

Access & Security 3

Authentication, authorization, and security posture

Operate 5

Status, limits, changes, and where to get help

Commercial 3

Pricing, plans, and the legal terms of use

Source (apis.yml)

apis.yml Raw ↑
aid: openfda
url: https://raw.githubusercontent.com/api-evangelist/openfda/refs/heads/main/apis.yml
apis:
- aid: openfda:openfda-animal-veterinary-api
  name: openFDA Animal & Veterinary API
  description: Adverse events involving animal and veterinary products.
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Animal & Veterinary
  properties:
  - type: OpenAPI
    url: openapi/openfda-animal-veterinary-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
- aid: openfda:openfda-device-api
  name: openFDA Device API
  description: Device-related endpoints (adverse events, classifications, recalls, 510(k), PMA, UDI).
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Device
  properties:
  - type: OpenAPI
    url: openapi/openfda-device-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
- aid: openfda:openfda-drug-api
  name: openFDA Drug API
  description: Drug-related endpoints (adverse events, labeling, recalls, NDC).
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Drug
  properties:
  - type: OpenAPI
    url: openapi/openfda-drug-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
- aid: openfda:openfda-food-api
  name: openFDA Food API
  description: Food-related endpoints (enforcement reports, adverse events).
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Food
  properties:
  - type: OpenAPI
    url: openapi/openfda-food-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
- aid: openfda:openfda-other-api
  name: openFDA Other API
  description: Cross-cutting datasets (NSDE, substance, harmonized).
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Other
  properties:
  - type: OpenAPI
    url: openapi/openfda-other-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
- aid: openfda:openfda-tobacco-api
  name: openFDA Tobacco API
  description: Tobacco product problem reports.
  humanURL: https://open.fda.gov/apis/drug/
  baseURL: https://api.fda.gov
  tags:
  - Tobacco
  properties:
  - type: OpenAPI
    url: openapi/openfda-tobacco-api-openapi.yml
  - type: Documentation
    url: https://open.fda.gov/apis/drug/
  - type: APIReference
    url: https://open.fda.gov/apis/drug/event/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/label/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/ndc/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/drugsfda/
  - type: Documentation
    url: https://open.fda.gov/apis/drug/shortages/
  - type: Documentation
    url: https://open.fda.gov/apis/device/
  - type: Documentation
    url: https://open.fda.gov/apis/device/event/
  - type: Documentation
    url: https://open.fda.gov/apis/device/classification/
  - type: Documentation
    url: https://open.fda.gov/apis/device/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/device/recall/
  - type: Documentation
    url: https://open.fda.gov/apis/device/510k/
  - type: Documentation
    url: https://open.fda.gov/apis/device/pma/
  - type: Documentation
    url: https://open.fda.gov/apis/device/udi/
  - type: Documentation
    url: https://open.fda.gov/apis/device/registrationlisting/
  - type: Documentation
    url: https://open.fda.gov/apis/device/covid19serology/
  - type: Documentation
    url: https://open.fda.gov/apis/food/
  - type: Documentation
    url: https://open.fda.gov/apis/food/enforcement/
  - type: Documentation
    url: https://open.fda.gov/apis/food/event/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/
  - type: Documentation
    url: https://open.fda.gov/apis/animalandveterinary/event/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/
  - type: Documentation
    url: https://open.fda.gov/apis/tobacco/problem/
  - type: Documentation
    url: https://open.fda.gov/apis/other/
  - type: Documentation
    url: https://open.fda.gov/apis/other/nsde/
  - type: Documentation
    url: https://open.fda.gov/apis/other/substance/
  - type: Documentation
    url: https://open.fda.gov/apis/other/historicaldocument/
name: openFDA
tags:
- Government
- Healthcare
- Drug
- Device
- Food
- Animal & Veterinary
- Tobacco
- Public Data
- Open Data
- Adverse Events
- Recalls
- Regulatory
kind: contract
accessModel:
  pricing: unknown
  onboarding: self-serve
  trial: false
  try_now: false
  public: false
  label: Self-serve signup
  confidence: medium
  source:
  - authentication
  generated: '2026-07-22'
  method: derived
image: https://kinlane-images.s3.amazonaws.com/shared/apis-json/icons/openfda.png
access: 3rd-Party
common:
- type: AgenticAccess
  url: agentic-access/openfda-agentic-access.yml
- type: DomainSecurity
  url: security/openfda-domain-security.yml
- type: Authentication
  url: authentication/openfda-authentication.yml
- url: https://open.fda.gov/
  name: openFDA
  type: Portal
- url: https://open.fda.gov/apis/
  name: API Endpoints
  type: Documentation
- url: https://open.fda.gov/apis/authentication/
  name: Authentication & API Keys
  type: Authentication
- url: https://api.data.gov/signup/
  name: api.data.gov Signup
  type: Signup
- url: https://open.fda.gov/apis/try-the-api/
  name: Try the API
  type: GettingStarted
- url: https://open.fda.gov/apis/query-parameters/
  name: Query Parameters Reference
  type: APIReference
- url: https://open.fda.gov/apis/query-syntax/
  name: Query Syntax (Lucene)
  type: APIReference
- url: https://open.fda.gov/apis/advanced-syntax/
  name: Advanced Query Syntax
  type: APIReference
- url: https://open.fda.gov/apis/errors/
  name: Error Reference
  type: ErrorCodes
- url: https://open.fda.gov/apis/downloads/
  name: Bulk Downloads
  type: Documentation
- url: https://open.fda.gov/about/status/
  name: openFDA Status
  type: StatusPage
- url: https://open.fda.gov/updates/
  name: openFDA Updates
  type: ChangeLog
- url: https://open.fda.gov/community/
  name: Community
  type: Forums
- url: https://github.com/FDA
  name: FDA GitHub Organization
  type: GitHubOrganization
- url: https://github.com/FDA/openfda
  name: openFDA on GitHub
  type: GitHubRepository
- url: https://github.com/FDA/open.fda.gov
  name: open.fda.gov web app
  type: GitHubRepository
- url: https://www.fda.gov/
  name: U.S. Food and Drug Administration
  type: Documentation
- url: https://www.fda.gov/about-fda/contact-fda
  name: Contact FDA
  type: Support
- url: https://creativecommons.org/publicdomain/zero/1.0/
  name: CC0 1.0 Universal — Public Domain
  type: License
- url: https://open.fda.gov/terms/
  name: openFDA Terms of Service
  type: TermsOfService
- url: https://www.fda.gov/about-website/website-policies
  name: FDA Privacy Policy
  type: PrivacyPolicy
- type: Rules
  url: rules/openfda-rules.yml
- type: SpectralRules
  url: rules/openfda-rules.yml
- type: JSONLD
  url: json-ld/openfda-context.jsonld
- type: Vocabulary
  url: vocabulary/openfda-vocabulary.yml
- type: RateLimits
  url: rate-limits/openfda-rate-limits.yml
- type: JSONSchema
  url: json-schema/openfda-search-response-schema.json
- type: Examples
  url: examples/openfda-drug-event-example.json
- type: Features
  data:
  - Six product-domain APIs (drug, device, food, animal & veterinary, tobacco, other) under a single api.fda.gov base URL
  - Twenty-two Lucene-queryable JSON endpoints sharing search, sort, count, limit, and skip parameters
  - Aggregation via the count parameter returns frequency histograms on any field without retrieving documents
  - Bulk download of every dataset as JSON archives partitioned for resumable transfer
  - Optional free api.data.gov API key lifts the per-IP daily quota from 1,000 to 120,000 requests
  - Per-minute ceiling of 240 requests/min applies uniformly to anonymous and keyed callers
  - Pagination capped at skip=25,000 with limit=1,000; deeper traversal requires bulk downloads
  - All endpoints are CC0 Public Domain — no attribution required for commercial or research reuse
  - Harmonized openfda block on most documents links each record back to NDC, UNII, SPL Set ID, and other identifiers
  - HTTPS-only with HTTP Basic or query-parameter key authentication
  - Public status page and email list for outage and breaking-change notifications
  - Active developer community via the openFDA GitHub organization and community forum
- type: UseCases
  data:
  - name: Adverse Event Surveillance
    description: Mine FAERS, MAUDE, CAERS, and animal/veterinary adverse event reports for safety signals across drugs, devices,
      foods, and animal products.
  - name: Recall Monitoring
    description: Subscribe to drug, device, and food recall enforcement reports and surface them in clinical, retail, or supply-chain
      dashboards.
  - name: Drug Labeling Apps
    description: Embed authoritative indications, dosage, warnings, and ingredient sections from Structured Product Labeling
      into consumer or clinical applications.
  - name: Regulatory Intelligence
    description: Track 510(k) clearances, PMA approvals, and Drugs@FDA submissions to monitor competitor and pipeline activity.
  - name: Identifier Resolution
    description: Look up NDC, UDI, UNII, and SPL Set IDs across product domains to power claims, EHR, and supply-chain integrations.
  - name: Public-Health Research
    description: Academic and journalistic investigation of adverse outcomes, recall patterns, and regulatory enforcement
      using CC0 public data.
  - name: Supply-Chain Risk
    description: Cross-reference drug shortage status, recall actions, and registration listings to detect upstream supply
      disruptions.
- type: Integrations
  data:
  - name: api.data.gov
    description: Federal API gateway that issues and enforces the openFDA API key, applying rate limits and quotas.
  - name: data.gov
    description: openFDA datasets are cataloged in the federal open-data portal as DCAT-compliant resources.
  - name: NIH RxNorm
    description: NDC and Drugs@FDA records are commonly joined with NIH RxNorm to align brand, generic, and ingredient terminology.
  - name: NLM DailyMed
    description: SPL drug labeling in openFDA mirrors NLM DailyMed, the authoritative SPL repository.
  - name: GUDID (Global UDI Database)
    description: openFDA device UDI records derive from FDA's Global Unique Device Identification Database.
  - name: FAERS Public Dashboard
    description: openFDA drug adverse event endpoint surfaces the same FAERS data exposed in FDA's public dashboard.
- type: Solutions
  data:
  - name: Pharmacovigilance
    description: Continuously ingest drug, device, and food adverse events for safety signal detection.
  - name: Recall and Withdrawal Alerting
    description: Power weekly recall enforcement notification workflows across drug, device, and food domains.
  - name: Regulatory Filings Intelligence
    description: Aggregate 510(k), PMA, and Drugs@FDA submissions for competitive analysis and pipeline tracking.
  - name: Clinical Decision Support References
    description: Surface FDA labeling content as a reference layer (explicitly not for clinical decision-making per openFDA
      terms).
  sources:
  - https://open.fda.gov/
  - https://open.fda.gov/apis/
  - https://open.fda.gov/apis/authentication/
  - https://open.fda.gov/apis/drug/
  - https://open.fda.gov/apis/device/
  - https://open.fda.gov/apis/food/
  - https://open.fda.gov/apis/animalandveterinary/
  - https://open.fda.gov/apis/tobacco/
  - https://open.fda.gov/apis/other/
  - https://github.com/FDA/openfda
  updated: '2026-05-25'
created: '2026-05-25'
modified: '2026-05-25'
position: Consuming
description: openFDA is the U.S. Food and Drug Administration's public data platform, providing Elasticsearch-backed REST
  APIs serving FDA-administered data on drugs, medical devices, foods, animal and veterinary products, and tobacco. Twenty-two
  endpoints under a single api.fda.gov base URL expose adverse event reports (FAERS, MAUDE, CAERS), recall enforcement reports,
  Structured Product Labeling, the National Drug Code Directory, Drugs@FDA approvals, drug shortages, device classification,
  510(k) and PMA submissions, Unique Device Identifier records, registration and listing, NSDE drug data, FDA substance harmonization,
  and historical FDA documents. All endpoints share a Lucene-style search, sort, count, limit, and skip parameter surface,
  are released under CC0 Public Domain, and operate under a free api.data.gov key that lifts daily quotas to 120,000 requests.
maintainers:
- FN: Kin Lane
  email: info@apievangelist.com
  X: apievangelist
  url: https://apievangelist.com
specificationVersion: '0.16'