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; 1,283,812
DailyMed labels: SPL metadata and sections; 5,796,232
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
1,283,812 label rows
Structured label metadata, SPL sections, label images, and document references.
RxNorm concepts
2,074 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
5,796,232 device rows
Medical device identification records with company, product code, and listing context.
GMDN terms
16,511 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)
104,367 rows
Premarket notification records with product code, device, applicant, and decision fields.
De Novo
621 rows
De Novo classification records and decision details.
Recalls
57,367 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.