Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Bioinformatics Tools

Bioinformatics Tools

                        Bioinformatics Publications
          Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)
          de novo Assembly Quality Evaluation Tool (dnAQET)
          FDALabel:  Full-Text Search of Drug Product Labeling


                        ArrayTrackTM HCA-PCA Standalone Package – powerful data-exploring tools
          Decision Forest
          Endocrine Disruptor Knowledge Base (EDKB)
          Estrogenic Activity Database (EADB)
          Liver Toxicity Knowledge Base (LTKB)
          MicroArray/Sequencing Quality Control (MAQC/SEQC)
          Mold2 Home
          Science & Research
          Bioinformatics Tools
          FDALabel:  Full-Text Search of Drug Product LabelingBioinformatics Tools FDALabel:  Full-Text Search of Drug Product Labeling
  
  					Web-based application to search labeling documents of FDA-approved drug products.
	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    Print****Overview of FDALabel DatabasePotential UsersWhat is Included in Drug Labeling?Database FeaturesLive Queries****Updates and StatisticsUser GuidesAdditional InformationOther ResourcesReferencesContact InformationDisclaimer


FDALabel Logo New gif
**To use FDALabel, select the link below or copy URL into browser:** 

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

FDALabel Version 2.7.1

Provide feedback or request assistance by contacting:

**NCTR Bioinformatics**

Overview of FDALabel DatabaseThe FDALabel Database is a web-based application used to perform customizable searches of over 140,000 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 August 28, 2023Human OTC Drugs*
			91,917Human Prescription Drugs and Biological Products**
			55,427Animal Prescription and Animal OTC Products
			3,471*  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 repurposing4as 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

Back to Top

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 foodsPrescribing 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, 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.Back to Top

FDALabel Live Queries and Use Cases

**Search Function**
			**Query Description******
			**Query***
			**Result******Labeling Full Text Search [Simple Search]**
			“Acute liver failure”
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525**Labeling Full Text Search [Simple Search]**
			“Respiratory depression”
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/116786
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/116786**Labeling Full Text Search [Advanced Search]**
			Biomarker “BRCA or BRAF”
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/116776
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/116776**Labeling Section(s) [Simple Search]**
			"Diabetes”within INDICATIONS AND USAGE
			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
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/110856
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/110856**Labeling Section(s)  [Advanced Search]**
			“Pregnancy or fetus” within BOXED WARNING
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/110851
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/110851**MedDRA Terms**
			"Acute hepatic failure [PT] and LLTs"
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/102842
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/102842**Pharmacologic Class(es)**
			Serotonin Uptake Inhibitors [MoA]
			https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/102754
			https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/102754*  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 weekly.



User Guides

FDALabel Handout
	FDALabel Quick Start Guide
	Simple Search Guide
	Advanced Search Guide
	Query Logic GuideAdditional Information

FDALabel Demo (video) | 2021 Global Summit on Regulatory Science (*GSRS*)
	FDALabel Presentation (PDF) | 2021 Global Summit on Regulatory Science (*GSRS*)Other Resources

Drug Approvals and DatabasesDrug Information for ConsumersInformation for Industry | DrugsLabeling Information | Drug ProductsPostmarket Drug Safety Information for Patients and ProvidersPrescription Drug Labeling ResourcesReferences

Structured Product Labeling Resources
	FDA Online Label Repository
	DailyMed
	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
	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
	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
	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
	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
	21 CFR 201.57Back to Top

Contact Information

Functions
			Contacts*Questions, Suggestions, or Get Assistance:*
			FDALabel Support (870-543-7538)*Report Technical Problems:*
			NCTRBioinformaticsSupport@fda.hhs.govDisclaimer

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.

Back to Top

Resources For You

About the National Center for Toxicological Research
	Bioinformatics Tools
	Get Email Updates for NCTR

                                                                                  Content current as of:
      08/28/2023
              
              
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Dietary Supplements
			     			  			     Drugs
			     			  			     Medical Devices
			     			  						              
						  Animal Cell-Based Products
			  			     			  			  
			 
			  Allergenics
			  			     			  			  
			
						   Medical Food/Beverage
			  			     			  			  
						  Inactive IngredientTopic(s)
			  New Animal Drug Application (NADA)Bioinformatics Tools

          
                        Publications
          Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)
          de novo Assembly Quality Evaluation Tool (dnAQET)
          FDALabel:  Full-Text Search of Drug Product Labeling


                        ArrayTrackTM HCA-PCA Standalone Package – powerful data-exploring tools
          Decision Forest
          Endocrine Disruptor Knowledge Base (EDKB)
          Estrogenic Activity Database (EADB)
          Liver Toxicity Knowledge Base (LTKB)
          MicroArray/Sequencing Quality Control (MAQC/SEQC)
          Mold2
 Subscribe to FDALabel E-mail Notifications
                        Get regular FDA email updates delivered on FDALabel news to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop