Data sources
14 archives are downloaded, checksummed, recorded and joined. Each entry below is the anchor target for the source markers that appear throughout the site — including on every block of prescribing information.
FDA Drugs@FDA — 12-table relational dump (tab-delimited)
FDAApplications, Products, Submissions, ApplicationDocs, ActionTypes_Lookup, MarketingStatus, TE and their lookup tables.
FDA Orange Book — flat data files (tilde-delimited)
FDAAuthoritative tilde-delimited flat files: products.txt, patent.txt, exclusivity.txt. Ingested to prove the composite-key parser and to diff against the openFDA JSON edition.
FDA Purple Book — Database of Licensed Biological Products
FDABiologics licensed under PHS Act 351(a) and 351(k), with biosimilar / interchangeable designations, reference products, and exclusivity dates.
openFDA — Drug Enforcement (Recalls)
FDADrug recall enforcement reports with classification and reason.
openFDA — Drug Shortages
FDACurrent and resolved drug shortage records.
openFDA — Drugs@FDA
FDACDER's regulatory action history: applications, products, submissions and review documents. Joined on zero-padded ApplNo + ProductNo.
openFDA — National Drug Code (NDC) Directory
FDAThe master catalogue of every drug product commercially listed in the United States, keyed on the 10-digit NDC product code. Supplies brand and generic names, labeler, dosage form, route, active ingredients with strengths, marketing category (NDA / ANDA / OTC monograph), DEA schedule, pharmacologic class, and package-level NDCs.
openFDA — Orange Book (JSON)
FDAApproved Drug Products with Therapeutic Equivalence Evaluations, in structured JSON. Supplies TE codes, RLD/RS flags, patents and exclusivity.
openFDA — Drug Labeling (Structured Product Labeling)
FDA / NLMSPL-derived prescribing information: indications and usage, dosage and administration, boxed warnings, warnings and cautions, adverse reactions, contraindications, drug interactions, mechanism of action and more. 262,886 label records across 14 partitions.
FDA Animal Drugs @ FDA (Green Book / CVM)
FDA CVMEvery approved animal drug application: NADAs, ANADAs, CNADAs and Index listings, with proprietary name, active ingredient, sponsor, approval status and voluntary withdrawal dates.
openFDA — Animal & Veterinary Adverse Events (VeDDRA)
FDA CVM1,357,337 veterinary adverse event records since 1987, coded in the VICH VeDDRA four-level hierarchy, including herd/flock aggregates, lack of expected efficacy reports and human operator exposure incidents.
DailyMed — Pharmacologic class mappings
NLMEstablished pharmacologic class (EPC), mechanism of action (MoA), chemical structure (CS) and physiologic effect (PE).
DailyMed — RxNorm mappings
NLMMaps SPL set IDs and NDCs to RxNorm CUIs — the clinical lingua franca join key.
DailyMed — SPL release file metadata
NLMManifest of DailyMed SPL release archives and their set IDs.
openFDA — Human Drug Adverse Events (FAERS)
FDAPost-market safety reports from the FDA Adverse Event Reporting System, ingested as aggregate report counts per active ingredient rather than as raw records. The bulk archive is 1,767 partitions totalling roughly 159 GB — not ingestible at any reasonable cost — so OpenRx queries the openFDA API for the total report count per ingredient and sums those onto each medication. See the methodology for why this figure must not be read as a risk measure.
What was built from them
| Entity | Rows |
|---|---|
| Medication entities | 47,843 |
| Active ingredients | 7,734 |
| NDC packages | 392,074 |
| Applications | 29,347 |
| Orange Book products | 97,522 |
| Patents | 22,303 |
| Exclusivities | 2,400 |
| Biologics | 2,243 |
| Animal drugs | 2,436 |
| Veterinary adverse events | 1,357,337 |
| Prescribing-information sections | 89,073 |
| Recalls | 17,975 |
| Shortages | 1,601 |