Overview of FDALabel Database
What is Included in Drug Labeling?
Updates and Statistics
Technical Recommendations to Improve Use
The FDALabel Database is a web-based application that allows you to perform customizable searches of a database of over 70,000 labeling documents that include human prescription drugs, biological products, and human over-the-counter (OTC) drugs.
The following table lists the number of labeling types in FDALabel.
Number of Labeling in FDALabel as of July 31, 2015
|Human OTC Drugs*||42,568|
|Human Prescription Drugs and Biological Products**||29,640|
* Includes human OTC drugs approved for marketing through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or the OTC monograph system.
** Includes drug products, therapeutic biologics and monoclonal antibodies, vaccines, plasma derivatives, allergenics (standardized and non-standardized), cellular therapy, and licensed minimally manipulated cells.
The source of FDALabel’s data is the FDA's Structured Product Labeling (SPL)1 archive2,3, which stores labeling documents submitted by manufacturers.
FDA does not verify the content of all the labeling on FDALabel and these labeling may be different than FDA-approved labeling.
Although some products on FDALabel may not be FDA-approved, they may be marketed if they comply with applicable regulations (e.g., OTC drugs regulated under the monograph system).
FDALabel is implemented as a secure three-tier platform with an Oracle database.
You can use the wealth of information in the FDALabel Database in many cases including as a healthcare provider for quick access to drug indications and warnings, as a pharmaceutical company for drug development, or as a researcher studying drug safety. For example, a recent publication demonstrated how a systematic classification scheme using FDA-approved drug labeling was developed to assess each drug’s potential for drug-induced liver injury, thus illustrating the utility of the FDALabel Database4.
The FDALabel Database includes the following types of labeling:
- Human prescription drug and biological product labeling including prescribing information, patient labeling, and carton and container labeling
- Drug products
- Therapeutic biologics and monoclonal antibodies
- Other biological products (e.g., blood products, allergenics, cellular theray)
- Human over-the-counter (OTC) labeling:
- Approved drugs
- Products marketed under the monograph system
Prescribing information for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. It includes indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, information about use in specific populations, and other important information for healthcare providers5. Associated patient labeling (i.e., Patient Information, Medication Guide, Instructions for Use) are directed to the patient, family, or caregiver. Associated container and carton labeling communicate information that is critical to the safe use of a medication from the initial prescription, to procurement, to preparation and dispensing of the product, to the time it is given to the patient.
Labeling for approved OTC drugs and OTC drugs under the monograph system is called Drug Facts. Drug Facts includes information about the purpose and use of the drug, warnings, directions for use, and other information.
You can perform a simple search in FDALabel (e.g., full-text search, product or generic name search for version 1.0) or an advanced search that allows searching for:
- Document types
- Marketing categories
- Presence of, or text within, specific sections of the prescribing information (e.g., BOXED WARNING, INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DRUG INTERACTIONS)
- SPL identifiers (e.g. Product NDC Codes and SETIDs)
- Market start/end date
You can save your search results in a spreadsheet format to your computer.
The database is updated quarterly. Statistics are posted on the main database page showing the total number of labeling and the number of newly added, updated, and removed labeling.
- Please use the Firefox or Google Chrome browser when you access FDALabel. Currently FDALabel does not work properly when using Internet Explorer or other browsers.
- The search will not work correctly if you use stop words or characters (such as: "_", "-", "*", "not", "and", "or", etc.).
- Structured Product Labeling Resources
- FDA Online Label Repository
- Chen, M.J., Vijay, V., Shi, Q., Liu, Z.C., Fang, H., and Tong, W.D. "FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury," Drug Discovery Today, 16(15-16):697-703, 2011. Abstract
- 21 CFR 201.57
|Questions, Suggestions, or Get Assistance:||Dr. Hong Fang (870-543-7538 or firstname.lastname@example.org)|
|Report Technical Problems:|| NCTRBioinformaticsSupport@fda.hhs.gov or
Steve Harris (email@example.com)
NCTR Bioinformatics Support
Food and Drug Administration
3900 NCTR RoadJefferson, AR 72079
Although the Structured Product Labeling (SPL) on FDALabel represents the most recent labeling that companies have submitted to FDA, the labeling has not been verified by FDA and may not be identical to the approved labeling or the labeling for currently distributed products. For the most recent FDA-approved labeling for humans visit:
- Prescription drug and biological products and over-the-counter (OTC) drugs (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
- Blood, vaccine, allergenic, or cellular/tissue products (http://www.fda.gov/BiologicsBloodVaccines/ucm121134.htm)
Many OTC drugs are not reviewed and approved by FDA (e.g., drugs marketed under a final monograph or a tentative final monograph); however, these OTC drugs may be marketed if they comply with applicable monographs. The labeling for drugs marked "OTC monograph final" or "OTC monograph not final" in FDALabel are not checked for conformance to the monograph.