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FDALabel: Full-Text Search of Drug Labeling

Web-based application to search labeling documents of FDA-approved drug products

FDALabel: Full-Text Search of Drug Labeling

Overview of FDALabel Database 
Potential Users
What is Included in Drug Labeling?
Database Features
Live Queries   NEW!!
Updates and Statistics
User Guides
References
Contact Information
Disclaimer

FDALabel Logo

To use FDALabel (version 2.3) select the link below or copy the URL into your browser:

https://nctr-crs.fda.gov/fdalabel/ui/search

FDALabel (version 2.3) beta testing in progress
Provide feedback or request assistance by contacting:
Dr. Hong Fang (870-543-7538 or hong.fang@fda.hhs.gov)or NCTR Bioinformatics (NCTRBioinformaticsSupport@fda.hhs.gov)

Overview of FDALabel Database

The FDALabel Database is a web-based application that allows you to perform customizable searches of a database of over 100,000 labeling documents that include human prescription drugs and biological products,and human over-the-counter (OTC) drugs.

Users can also search for a number of medical devices (>1100), animal prescription and animal OTC drugs (>3000), and other products.

The following table lists the number of several labeling types in FDALabel.

Labeling Types

Number of Labeling in FDALabel as of May 14, 2019

Human OTC Drugs*

63,890

Human Prescription Drugs and Biological Products**

39,179

Animal Prescription and Animal OTC Products

3,185

Medical Devices

1,186

*   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.

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, unapproved homeopathic drugs, and unapproved dietary supplements).

FDALabel is implemented as a secure three-tier platform with an Oracle database.

Potential Users

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 safety4. 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 Database5.

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What is Included in Drug Labeling?

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
    • 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
  • Unapproved homeopathic prescription and homeopathic OTC products
  • Other types of labeling:
    • Animal prescription and animal OTC products
    • Medical devices
    • Dietary supplements
    • Cosmetics
    • Medical foods

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 providers6. 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.

Homeopathic prescription and homeopathic OTC drugs are not approved by the FDA but are allowed to be marketed. There are minimal labeling requirements for these unapproved products.

Database Features

You can perform a simple search in FDALabel (e.g., full-text search, product or generic name search) 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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FDALabel Live Queries and Use Cases

Search Function

Query Description 

Query

Result

Labeling Full Text Search

“Acute liver failure”

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/5780

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/5780

Labeling Full Text Search

“Monitor for sedation and respiratory depression”

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/10525

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/10525

Labeling Full Text Search

Biomarker “BRCA”

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/10537

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/10537

Labeling Section(s)

"Acute liver failure within BOXD WARNING

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/5785 https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/5785

Labeling Section(s)

“Diabetes” within INDICATIONS AND USAGE

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/10526

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/10526

Labeling Section(s)

“Beta blocker” within DRUG INTERACTIONS

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/9565

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/9565

Pharmacologic Class(es)

Serotonin Uptake Inhibitors [MoA]

https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/9537

https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/9537

Updates and Statistics

Drug Labeling Data within FDALabel is updated monthly.

User Guides

References

  1. Structured Product Labeling Resources

  2. FDA Online Label Repository

  3. DailyMed

  4. Fang H., Harris S.C., Liu Z., Zhou G., Zhang G., Xu J., Rosario L., Howard P.C., and Tong W. “FDA Drug Labeling: Rich Resources to Facilitate Precision Medicine, Drug Safety, and Regulatory Science.” Drug Discovery Today. 21 (10), 1566-1570. Abstract

  5. 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. 2011, 16(15-16):697-703. Abstract

  6. 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)

 NCTR Bioinformatics Support
 Food and Drug Administration
 3900 NCTR Road
 Jefferson, AR 72079

Disclaimer

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:

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. 

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