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FDALabel: Full-Text Search of Drug Product Labeling

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


Overview of FDALabel Database
FDALabel Database Access
Potential Users
What is Included in Drug Labeling?
Database Features
Live Queries  
Updates and Statistics
User Guides
Additional Information
Other Resources
Contact Information

FDALabel Logo New gif

To use FDALabel, select the link below or copy URL into browser: 


FDALabel Version 2.9
Provide feedback or request assistance by contacting:
NCTR Bioinformatics

Overview of FDALabel Database

The FDALabel Database is a web-based application used to perform customizable searches of over 147,000 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) archive,1-3 which stores labeling documents submitted by manufacturers. FDALabel is implemented as a secure three-tier application with an Oracle database. 

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

Labeling Types

Number of Labeling as of July 9, 2024

Human OTC Drugs*


Human Prescription Drugs and Biological Products**


Animal Prescription and Animal OTC Products


 *  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, 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 safety. For example, recent publications describe how information in drug labeling can be used to aid and facilitate drug repurposing4 as well as applications in precision medicine, drug safety, and regulatory science.5-7 Another publication demonstrated how a systematic classification scheme using FDA-approved drug labeling was developed to assess a drug’s potential for drug-induced liver injury, thus illustrating the utility of FDALabel Database.8

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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 providers9. 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, DailyMedDrugs@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 



Labeling Full Text Search [Simple Search]

“Acute liver failure”



Labeling Full Text Search [Simple Search] 

“Respiratory depression”



Labeling Full Text Search [Advanced Search] 

Biomarker “BRCA or BRAF”



Labeling Section(s) [Simple Search] 


https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/110855 https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/110855

Labeling Section(s) [Simple Search]

"Beta blocker" within DRUG INTERACTIONS 



Labeling Section(s)  [Advanced Search] 

“Pregnancy or fetus” within BOXED WARNING



MedDRA Terms

"Acute hepatic failure [PT] and LLTs"



Pharmacologic Class(es)

Serotonin Uptake Inhibitors [MoA]



 *  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


To use FDALabel, select the link below or copy URL into browser: 



Updates and Statistics

Drug Labeling Data within FDALabel is updated weekly.

User Guides

Additional Information

Other Resources


  1. Structured Product Labeling Resources

  2. FDA Online Label Repository

  3. DailyMed

  4. Fang H., Harris S.C., Liu Z., Thakkar S., Yang J., Ingle T., Xu J., Lesko L., Rosario L., and Tong W. "FDALabel for drug repurposing studies and beyond." Nature Biotechnology. 2020, 38:1378-1379. Abstract

  5. Ying L., Liu Z., Fang H., Kusko R., Wu L., Harris S., and Tong W. "Text summarization with ChatGPT for drug labeling documents." Drug Discovery Today. 2024, 29(6), 104018. Abstract

  6. Mehta D., Uber R., Ingle T., Li C., Liu Z., Thakkar S., Ning B., Wu L., Yang J., Harris S.C., Zhou G., Xu J., Tong W., Lesko L., and Fang H. "Study of Pharmacogenomic Information in FDA-approved Drug Labeling to Facilitate Application of Precision Medicine." Drug Discovery Today. 2020, 25(5), 813-820. Abstract

  7. Wu L., Ingle T., Liu Z., Zhao-Wong A., Harris S.C., Thakkar S., Zhou G., Yang J., Xu J., Mehta D., Ge W., Tong W., ang Fang H. "Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA." BMC Bioinformatics. 2019, 20(97). Abstract

  8. 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. 2016, 21(10):1566-1570. Abstract

  9. 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

  10. 21 CFR 201.57

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Contact Information



 Questions, Suggestions, or Get Assistance:

 FDALabel Support  (870-543-7538)

 Report Technical Problems: 



Data Source
The source of FDALabel’s data is DailyMed's Structured Product Labeling (SPL) archive which contains the most recent labeling documents submitted by companies ("in use" labeling). 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 that are undergoing FDA review (e.g., added or strengthening a warning or adverse reaction).

For information regarding types of changes to labeling that may result in differences between the SPL labeling 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 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.

Nonprescription Drugs
Many nonprescription drugs (e.g., 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 OTC monographs. The labeling for drugs marked "OTC monograph final" or "OTC monograph not final" in FDALabel are not checked for conformance to the monograph. A search for the "Human OTC Drugs" labeling in FDALabel retrieves nonprescription drugs that are OTC as well as nonprescription products available behind the pharmacy counter (e.g., nonprescription insulin products).

MedDRA Terms Search and Report
The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MedDRA features developed in FDALabel are intended to facilitate the study of adverse event (AE) occurrences in product labeling. It should be noted that MedDRA version updates, which occur on a biannual basis, may affect search results due to changes in mapping or promotion/demotion of MedDRA terms. FDALabel updates MedDRA terminology at least once a year during a new version release. The FDA does not require AEs to be described with MedDRA terminology in labeling. Thus, a MedDRA term search or report in FDALabel may not represent all AE concepts represented in labeling. Furthermore, the presence of a MedDRA term in labeling may not necessarily refer to an AE (e.g., MedDRA terms may correspond to indications or patient comorbidities). During the application of the MedDRA features in FDALabel, specific rules (see PDF) were defined for applying Natural Language Processing (NLP) using MedDRA. Labeling documents (SPL: Structured Product Labeling) are indexed by MedDRA Lowest Level Terms (LLTs) following the predefined MedDRA rules. MedDRA LLTs, extracted from a SPL, are mapped to Preferred Terms (PTs) for the MedDRA report.

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