The Federal Food, Drug, and Cosmetic Act authorizes FDA to require that prescription drug labeling provides healthcare professionals and patients with adequate information to permit safe and effective use of drug products. The Public Health Service Act provides legal authority for the agency to regulate the labeling and shipment of biological products. Labeling is reviewed as part of a Biologics License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), their respective supplements, annual reports, and promotional material. For the most current guidance, refer to Search for FDA Guidance Documents.

This website does not include labeling resources for Medical Devices.

Prescribing Information

Structured Product Labeling (SPL)

Patient Labeling

Medication Guides (MG)
Patient Package Inserts (PPI)
- PPIs are voluntary for prescription drug products except for oral contraceptives and estrogen-containing products
Guidance Documents

Package and Carton/Container Labeling

Promotional Materials

ANDA Labeling Resources

Additional Resources

FDA’s Labeling Resources for Human Prescription Drugs
21 CFR PART 201 Labeling Subpart A – General Labeling Provisions
Pediatric Research Equity Act (PREA)
Purple Book
The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products.
The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).
Drugs@FDA
Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQs), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (see Biologics Products & Establishments). for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.
FDALabel
Web-based application to search labeling documents of FDA-approved drug products.
DailyMed
DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.
FDA Online Label Repository
The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA).
Guidance Documents