Data source

Data from U.S. FDA openFDA, delivered clean.

7 datasets pulled from U.S. FDA openFDA's releases, checked field by field and shipped the way you want them — daily, weekly, or hourly, your call.

  • 7 datasets
  • 2 industrys
  • Real rows on request

Drug Retail

4
Drug Retail United States regulatory perimeter · Enforcement reports from 2004 to present

openFDA Drug Enforcement / Recall API

Drug Retail United States · Bulk of data June 2009 to present (some earli…

openFDA Drug Label API (Structured Product Labeling)

Drug Retail United States regulatory perimeter - approval… · Approvals since 1939

openFDA Drugs@FDA API

Drug Retail Global submissions to the US FDA - United Sta… · 2004 Q1 to present

openFDA FAERS Adverse Event API

Health Care Supplies

3
Health Care Supplies Devices marketed in the United States · 1976 to present

openFDA Device 510(k) Clearances API

Health Care Supplies United States enforcement actions against FDA… · Classified recalls from November 1

openFDA Device Recalls API

Health Care Supplies Devices distributed in the United States · Device identifier filings from the 2013 UDI r…

openFDA Unique Device Identifier (GUDID) API

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Straight answers about U.S. FDA openFDA data

How many records sit on the U.S. FDA openFDA shelf?

More than 26.3 million across seven collections. FAERS dominates with 20.7 million safety reports since 2004, followed by 5.1 million device identifier records, 262,000 drug label versions, 176,000 device clearances, 59,000 device recall events, 29,000 drug applications and 17,900 drug enforcement reports.

What is the difference between the drug and device recall collections?

Different universes with parallel shapes. The drug shelf carries 17,876 enforcement reports from 2004 onward, graded Class I through III by hazard. The device shelf carries 58,999 recall events classified since November 2002, adding firm-initiated corrections from January 2017, with root causes, corrective actions and lot codes attached.

Can one adverse event report prove a drug caused a reaction?

No - and the structure says so plainly. When several drugs and several reactions appear in a single report, no causal pairing between any specific drug and reaction can be drawn. Counts reflect reporting behavior as much as incidence, which is why signal-detection work needs all 20.7 million rows rather than summaries.

How far back do the approval histories reach?

To 1939 for the drug applications themselves, with attached labels, approval letters and reviews concentrated after 1998. Each application nests its products - ingredients, strengths, dosage form, route, marketing status, therapeutic-equivalence codes - and its submissions, each stamped with the date it reached approved or tentative-approval status, which is what makes timelines buildable.