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The following table lists the number of several labeling types in FDALabel.
Labeling Types Number of Labeling as of March 17, 2021
Human OTC Drugs* 88,579
Human Prescription Drugs and Biological Products** 48,950
Animal Prescription and Animal OTC Products 3,202

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.

Labeling Types Query Description Query* Result**
Labeling Full Text Search [Simple Search] “Acute liver failure” https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
Labeling Full Text Search [Simple Search] “Respiratory depression” https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
Labeling Full Text Search [Simple Search] Biomarker “BRCA or BRAF” https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
Labeling Full Text Search [Simple Search] “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
“Beta blocker” within DRUG INTERACTIONS “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
“Pregnancy or fetus” within BOXED WARNING “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
“Pregnancy or fetus” within BOXED WARNING “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
Labeling Full Text Search [Simple Search] “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525
Labeling Full Text Search [Simple Search] “Diabetes” within INDICATIONS AND USAGE https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/106525 https://nctr-crs.fda.gov/fdalabel/ui/search/spl-summaries/criteria/106525