FDA.report

Public FDA records across drugs, devices, labels, recalls, adverse events, applications, substances, standards, and product classifications.

428,125
NDC products
Drug listings and packages
1,324,814
DailyMed labels
SPL metadata and sections
4,462,490
GUDID devices
Device identifiers
9,402,726
MAUDE reports
Adverse-event records

Common lookups#

Sample NDC record

Drug listing

Open a drug product page with packages, ingredients, harmonized identifiers, and related labels.

Sample DailyMed label

Structured label

Review SPL label metadata, sections, images, and related drug records.

Recent recalls

Safety records

Scan current imported enforcement and device recall records.

Company filings

Company lookup

Find public FDA records grouped by company name.

FDA datasets#

NDC directory

428,125 product rows

Drug product and package listings with labeler, ingredient, package, and marketing fields.

DailyMed labels

1,324,814 label rows

Structured label metadata, SPL sections, label images, and document references.

RxNorm concepts

159 concept rows

Drug vocabulary concepts connected to NDC, DailyMed, UNII, and source vocabulary codes.

Drug applications

28,815 application rows

Applications, products, submissions, review documents, and approval history.

UNII substances

207,363 substance rows

Substance identifiers, preferred terms, registry numbers, formulas, and linked drug records.

MeSH terms

18,411 descriptor rows

Medical subject descriptors connected to substances and related terminology.

GUDID devices

4,462,490 device rows

Medical device identification records with company, product code, and listing context.

GMDN terms

15,739 indexed terms

Device terms and definitions derived from active GUDID device records.

Product codes

4,083 legacy rows

FDA medical device product-code classifications and related premarket records.

PMA

33,705 rows

Premarket approval records, supplements, applicants, decisions, and documents.

PMN / 510(k)

103,623 rows

Premarket notification records with product code, device, applicant, and decision fields.

De Novo

620 rows

De Novo classification records and decision details.

Recalls

57,337 rows

Recall enforcement and device recall records with firm, product, reason, and status.

MAUDE

9,402,726 report rows

Medical device adverse-event reports connected to devices, product codes, and companies.

Recognized standards

775 rows

FDA-recognized consensus standards with organization, status, and recognition date.