DailyMed Drug Label Database

Overview

DailyMed is the National Library of Medicine's official repository of FDA-approved drug labeling information, containing 140,000+ structured product labels (SPLs) for prescription drugs, OTC medications, biologics, and vaccines. The REST API (v2) provides structured JSON/XML access to the full label content including indications, dosage, warnings, contraindications, adverse reactions, and packaging data — with no authentication required.

When to Use

• Retrieving official FDA-approved prescribing information for a drug by name, NDC code, or set ID
• Extracting structured label sections (indications, warnings, dosage, adverse reactions) for pharmacological research
• Looking up all marketed formulations of an active ingredient with packaging and NDC codes
• Cross-referencing drug labels using RxCUI identifiers from RxNorm integration
• Building drug information pipelines that require authoritative FDA label content (not user-reported data)
• Comparing label content across brand name and generic formulations of the same drug
• For adverse event reports from FAERS, use fda-database instead; DailyMed contains label text, not post-market safety signals
• For drug-drug interaction severity data, use ddinter-database; DailyMed label text is unstructured for interactions

Prerequisites