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; 1,288,850
DailyMed labels: SPL metadata and sections; 5,810,073
GUDID devices: Device identifiers; 10,068,056
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
1,288,850 label rows
Structured label metadata, SPL sections, label images, and document references.
RxNorm concepts
4,749 concept rows
Drug vocabulary concepts connected to NDC, DailyMed, UNII, and source vocabulary codes.
Purple Book biologics
2,173 product rows
Licensed biological products, biosimilars, interchangeable products, historical releases, exclusivity, and patents.
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
5,810,073 device rows
Medical device identification records with company, product code, and listing context.
GMDN terms
16,587 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
34,033 rows
Premarket approval records, supplements, applicants, decisions, and documents.
PMN / 510(k)
91,298 rows
Premarket notification records with product code, device, applicant, and decision fields.
De Novo
622 rows
De Novo classification records and decision details.
Recalls
108,429 rows
Recall enforcement and device recall records with firm, product, reason, and status.
MAUDE
10,068,056 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.