# openFDA

License: restricted (LicenseRef-U-S-Food-and-Drug-Administration-terms); Mdexa hosting: link-only. a restricted part cannot be separated or the boundary is unstated: strictest part applies. Second check: commercial_use read more strictly (unstated to conditional); derivatives read more strictly (unstated to conditional); redistribution read more strictly (unstated to conditional).

- Commercial use: Conditional · Derivatives: Conditional · Redistribution: Conditional · File on Mdexa: No
- License status: Restricted (LicenseRef-U-S-Food-and-Drug-Administration-terms)
- Mdexa hosting: Link only — License restricted, judged by public rules and checked by a second-pass model. Link only.
- Last verified: 2026-11-13
- Card: https://mdexa.com/datasets/openfda/

## Key facts

- Domain: Pharmacy and drugs, Standards and terminology
- Content type: Databases
- Size: —
- Language: English
- Modality: Text
- Publisher: U.S. Food and Drug Administration
- Year: —

## Commercial use of openFDA

- Commercial use: Conditional.
The overall verdict takes the strictest part; the parts carry different licenses, listed below.
- License status: Restricted.
- Conditions: Attribution
- License part: main data — Permissive (LicenseRef-PublicDomain)
- License part: copies of copyrightable works made available to the FDA by private entities — Restricted (NOASSERTION)
- License part: GMDN Content — Restricted (NOASSERTION)
Verdicts record what sources state and are not legal advice.

## openFDA license evidence

a restricted part cannot be separated or the boundary is unstated: strictest part applies

- **Terms of use page**: Statement found in snapshot s02 (page) — "Use of the data made available via openFDA is generally unrestricted (see “Data Rights and Usage”)." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Site policy page** — CC0-1.0: Statement found in snapshot s02 (page) — "Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page** — CC0-1.0: Statement found in snapshot s02 (page) — "You can copy, modify, distribute, and perform the work, even for commercial purposes, all without asking permission." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Site policy page**: Statement found in snapshot s02 (page) — "Some data on openFDA may not be public domain, such as copies of copyrightable works made available to the FDA by private entities." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "While not required, when using content, data, documentation, code, and related materials from openFDA in your own work, we ask that proper credit be given." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "Your use of openFDA may be subject to certain limitations on access, calls, or use as set forth within this Agreement or otherwise provided by FDA." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "GMDN® is a registered trademark of The GMDN Agency. All rights reserved." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "mapping to other categorizations or ontologies, or for AI training purposes, must first obtain an appropriate license from The GMDN Agency. No such activity is permitted without a license." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "Therefore, your rights to use those works may be similarly limited." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "However, the service through which we make that data available is offered subject to your acceptance of the terms and conditions contained herein as well as any relevant sections of the FDA Website Policies." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "FDA reserves the right (though not the obligation) to refuse to provide openFDA to you if it is FDA’s opinion that use violates any FDA or Federal policy or law." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Terms of use page**: Statement found in snapshot s02 (page) — "The information provided on this site includes data supplied by The GMDN Agency (“GMDN Content”), which is used under license from The GMDN Agency." — https://open.fda.gov/terms/ (2026-11-12; Page opened)
- **Dataset page**: Part "copies of copyrightable works made avail" found in snapshot s02 (page) — "Some data on openFDA may not be public domain, such as copies of copyrightable works made available to the FDA by private entities. FDA may make these works available under the fair use provision of the Copyright Act" — https://open.fda.gov/terms/ (2026-11-12; Page opened)

## Source and lineage

—

## Known issues with openFDA

- FDA does not warrant that openFDA data is error free, or that access to it will be continuous or uninterrupted.

## Preflight

Not run (data not ingested).

## Downloading openFDA and API access

Mdexa does not serve files. Original source:
- https://open.fda.gov/
- https://open.fda.gov/terms/

### Access recipe

- /cosmetic/event data · https://download.open.fda.gov/cosmetic/event/cosmetic-event-0001-of-0001.json.zip
- /food/enforcement data · https://download.open.fda.gov/food/enforcement/food-enforcement-0001-of-0001.json.zip
- /food/event data · https://download.open.fda.gov/food/event/food-event-0001-of-0001.json.zip
- /drug/ndc data · https://download.open.fda.gov/drug/ndc/drug-ndc-0001-of-0001.json.zip
- /drug/drugsfda data · https://download.open.fda.gov/drug/drugsfda/drug-drugsfda-0001-of-0001.json.zip
- /drug/shortages data · https://download.open.fda.gov/drug/shortages/drug-shortages-0001-of-0001.json.zip
- /drug/enforcement data · https://download.open.fda.gov/drug/enforcement/drug-enforcement-0001-of-0001.json.zip
- /drug/orangebook data · https://download.open.fda.gov/drug/orangebook/drug-orangebook-0001-of-0001.json.zip
- /device/510k data · https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- /device/classification data · https://download.open.fda.gov/device/classification/device-classification-0001-of-0001.json.zip
- /device/enforcement data · https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- /device/pma data · https://download.open.fda.gov/device/pma/device-pma-0001-of-0001.json.zip

## Citing openFDA

No recommended citation text.

## Machine-readable

- JSON: https://mdexa.com/datasets/openfda.json
- 2026-11-13 Listed on 2026-11-13. Judged by public rules and checked a second time before listing. Second check: commercial_use read more strictly (unstated to conditional); derivatives read more strictly (unstated to conditional); redistribution read more strictly (unstated to conditional).

## Continue in this database

This record is one of 109 processed and verified records (datasets, data resources and open models). To find others, call `https://mcp.mdexa.com/v1/datasets?q=<words>` or connect the MCP server at `https://mcp.mdexa.com/mcp`; no key is needed for 20 calls per minute. Rows are under 1 KB; an empty result means "not listed". For a list of items, one batch check (free account) returns a report. Guide: /agents.md. Similar records: DrugCentral (https://mdexa.com/datasets/drugcentral/); RxNorm (https://mdexa.com/datasets/rxnorm/); ATC/DDD Index (https://mdexa.com/datasets/atc-ddd/).
