Science & Research

FDALabel: Full-Text Search of Product 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 Product 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 search a database of about 70,000 labeling documents that include human prescription drugs, biological products, and human over-the-counter (OTC) drugs using customizable searches. 

You can also search for a number of human devices, human vaccines, prescription and OTC animal products, and other products.  The following table lists the top ten labeling types in FDALabel.

Top Ten Labeling Types in FDALabel

Top Ten
Labeling Types

FDALabel Info
On February 27, 2015

Percentage of 
all Labeling 

Human OTC  39096  55.40% 
Human Prescription  27306  38.69% 
Animal OTC  1545  2.19% 
Medical Device  1126  1.60% 
Animal Prescription  702  0.99% 
Bulk Ingredient  132  0.19% 
Dietary Supplement  132  0.19% 
OTC Type A Medicated Article Animal 117 0.17% 
Plasma Derivative  115  0.16% 
Vaccine  87  0.12%
All Labels in SPL 70571 100%

The source of FDALabel’s data is from 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 documents on FDALabel and these labeling documents may be different than FDA-approved labeling (for FDA-approved labeling for human drug and biological products, see Drugs@FDA. Although some products on FDALabel may not be FDA-approved, they may be marketed if they comply with applicable regulations (e.g. OTC monographs, unapproved homeopathic drugs, and unapproved dietary supplements).

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 health care provider for quick access to drug indications and warnings, as a pharmaceutical company for drug development, as a researcher studying drug safety, etc. For example, a recent publication demonstrated how a systematic classification scheme using FDA-approved drug labeling documents was developed to assess each drug’s potential for drug-induced liver injury, thus illustrating the utility of the FDALabel Database3.

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What is Included in Product Labeling?

This FDALabel database includes the following types of labeling:

  • Human prescription drug and biological product labeling including professional labeling (i.e., prescribing information), patient-labeling, and carton and container labeling
  • Human over-the-counter (OTC) labeling:
    • Approved drugs
    • Products marketed under the monograph system
  • Unapproved homeopathic prescription and OTC drugs
  • Other types of labeling:
    • Animal prescription and OTC drugs
    • Some medical devices
    • Some vaccines

Prescribing information for 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 providers2. Associated patient labeling documents (i.e., Patient Information, Medication Guide, Patient's Instructions for Use) are directed to the patient, family, or caregiver. Associated container and carton labeling documents 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.

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

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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 documents and the number of newly added, updated, and removed labeling documents.
 

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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. We are working to solve this problem.
  2. The search will not work correctly if you have stop words (such as: "_", "-", "*", etc.).
     

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References

1. Structured Product Labeling Resources  
2. 21 CFR 201.57
3. 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 

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Contact Information

 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: 04/16/2015
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