Science & Research

FDALabel: Full-Text Search of Drug Labeling

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 FDA over LABEL in blue on a grey background with five pills of various colors and sizes in upper right corner
 

 

Launch FDALabel Version 1.0 Using Firefox or Google Chrome

 

FDA Users: The FDA version is available on the intranet under "Information Technology/NCTR Applications" and is updated weekly.

Overview of FDALabel Database
Potential Users
What is Included in Drug Labeling?
Database Features
Updates and Statistics
Launch FDALabel Database
Technical Recommendations to Improve Use
References
Contact Information

Overview of FDALabel Database

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.

Labeling Types in FDALabel

Labeling Types

Number of Labeling in FDALabel as of July 31, 2015

Human OTC 42,568
Human Prescription 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 Structured Product Labeling (SPL)1 archive of DailyMeddisclaimer icon, which stores labeling documents submitted by manufacturers.

FDA does not verify the content of the labeling on FDALabel and these labeling may be different than FDA-approved labeling.

For FDA-approved labeling for human drug and biological products, see Drugs@FDA. For a list of vaccines licensed for immunization and distribution in the United States see vaccines.

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.

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Potential Users

You can use the wealth of information in the FDALabel Database as a healthcare provider for quick access to drug indications and warnings, and as a pharmaceutical company for drug development, 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 Database.

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What is Included in Drug Labeling?

This 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
    • Vaccines
    • 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 providers. 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 the Drug Facts. Drug Facts includes information about the purpose and use of the drug, warnings, directions for use, and other information.

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Database Features

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. 

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Updates and Statistics

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.
 

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Launch FDALabel Database Using Firefox or Google Chrome

Launch FDALabel Version 1.0

FDA Users: The FDA version is available on the intranet under "Information Technology/NCTR Applications" and is updated weekly.

Technical Recommendations To Improve Use

  1. 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. 
  2. The search will not work correctly if you have stop words (such as: "_", "-", "*", "not", "and", "or", etc.).
     

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References

1. Structured Product Labeling Resources  

2. 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 disclaimer icon 

3. 21 CFR 201.57
 

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Contact Information

 Functions Contacts
 Questions, Suggestions, or Get Assistance: Dr. Hong Fang (870-543-7538 or hong.fang@fda.hhs.gov)
 Report Technical Problems:  NCTRBioinformaticsSupport@fda.hhs.gov or
 Steve Harris (stephen.harris@fda.hhs.gov)

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Page Last Updated: 08/25/2015
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