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FDALabel: Full-Text Search of Drug Labeling

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

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 New gif

To use FDALabel (version 2.4) select the link below or copy the URL into your browser:

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

FDALabel (version 2.4) beta testing in progress

Provide feedback or request assistance by contacting:

Dr. Hong Fang (870-543-7538) or NCTR Bioinformatics

Overview of FDALabel Database

The FDALabel Database is a web-based application used to perform customizable searches of over 110,000 human prescription, biological, over-the-counter (OTC), and animal drug labeling documents. The source of FDALabel's data is the FDA's Structured Product Labeling (SPL)1 archive2,3, which stores labeling documents submitted by manufacturers. FDALabel is implemented as a secure three-tier platform with an Oracle database. 


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

Labeling Types

Number of Labeling in FDALabel as of September 16, 2019

Human OTC Drugs*

65,536

Human Prescription Drugs and Biological Products**

46,531

Animal Prescription and Animal OTC Products

3,173

Medical Devices

1,238

 *  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.

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 FDALabel Database5.

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What drug labeling is included in the database?

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 therapy)
  • Human over-the-counter (OTC) labeling:
    • Approved drugs
    • Products marketed under the monograph system
  • Unapproved homeopathic prescription and homeopathic OTC products
  • Animal prescription and animal OTC product labeling
  • Other types of labeling:
    • 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 (e.g., 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

  • Ability to conduct full text searches of the entire labeling or specific sections/subsections of labeling.
  • Perform complex queries with functions that allow 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, UNIIs, SETIDs)
    • Market start/end date
    • Pharmacologic Classes
  • Results include direct links to the SPL document, DailyMed, Drugs@FDA, and Orange Book.
  • Export labeling results to a spreadsheet format to save and open in Excel.
  • Permanent links that allow users to save and share queries with colleagues. 

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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 BOXED 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

 *  Click the Query link to view, edit, and repeat the query
** Click the Result link to view labeling results, download full results, and view the query permanent link

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)

 Report Technical Problems: 

 NCTRBioinformaticsSupport@fda.hhs.gov or
 Steve Harris

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

Disclaimer

Data Source
The source of FDALabel’s data is FDA’s Structured Product Labeling (SPL) archive of the most recent labeling documents submitted by companies. The SPL documents found on FDALabel are also found on DailyMed and FDA Online Label Repository.

Differences Between SPL and FDA-Approved Labeling
The labeling in the SPL documents may not be identical to the most recent FDA-approved labeling available at Drugs@FDA, and the contents of the SPL documents (including data element entries in the SPL files) have not been verified by the FDA. For example:

  • The dosage form(s) listed in the output page are derived from the Data Standards Manual (DSM) terminology and may not be consistent with United States Pharmacopeia (USP) terminology or dosage forms terminology used in FDA-approved labeling.
  • The marketing date(s) listed may not always accurately represent the date that the product was first marketed.
  • Compared with the most recent FDA-approved labeling, the SPL document may contain minor changes (e.g., editorial changes such as adding a distributor’s name) or moderate changes (e.g., added or strengthened warning or adverse reaction) that are undergoing FDA review.

For information regarding types of changes to labeling that may cause the SPL document to differ from the most recent FDA-approved labeling, see 21 CFR 314.70, 21 CFR 601.12, and the Guidance for Industry: Changes to an Approved NDA or ANDA.

Because the SPL documents on FDALabel may not be identical to the most recent FDA-approved labeling, visit the following sites for the most current FDA-approved labeling:

  • Drugs@FDA for human prescription drug and biological products and for over-the-counter (OTC) drugs approved under an NDA or ANDA;
  • Biologics Products & Establishments for human blood and blood products; plasma derivatives; vaccine, allergenic, and cellular and gene therapy products; and products regulated by CBER under an NDA or ANDA (e.g., Plasma Volume Expanders).

Limitations of Product Title Search of PLR Format Labeling
Because of how SPL documents are structured, an FDALabel product title search of PLR format labeling (performed via the "Product Title" option in the Labeling Section(s) search box) may include some labeling for which the queried text is not in the product title. For example, the product title search may result in some labeling that have the queried text appearing in the Highlights Limitation Statement, the Initial U.S. Approval, or the biosimilarity statement for biosimilar products.

OTC Drugs
Many OTC drugs are not reviewed and approved by the 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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