DailyMed Overview

The DailyMed database contains labeling, submitted to the Food and Drug Administration (FDA) by companies, for the following products:

  • FDA-approved products:
    • Prescription drug and biological products for human use (labeling includes Prescribing Information, patient labeling, and carton and container labeling):
      • Drug products, and
      • Biological products
    • Nonprescription (e.g., over-the-counter) drug and biological products for human use
    • Certain medical devices for human use
    • Medical gases for human and animal use
    • Prescription and nonprescription drugs for animal use
  • Additional products regulated, but not approved, by the FDA:
    • Certain medical devices
    • Cosmetics
    • Dietary supplements
    • Medical foods
    • Unapproved prescription and nonprescription products

The Prescribing Information (PI) 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. The PI includes boxed warnings, indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, information about use in specific populations, and other important information for healthcare practitioners. FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use) is directed to the patient, family, or caregiver. FDA-approved carton and container labeling communicate information that is critical to the safe use of prescription drug and biological products from the initial prescription, to procurement, to preparation and dispensing of the drug, to the time it is given to the patient.

Labeling for nonprescription drugs is called Drug Facts. Drug Facts includes the following information about the drug: its purpose, warnings, directions for use, and other information.

The labeling on DailyMed is the most recent submitted labeling to the FDA by companies and currently in use (i.e., "in use" labeling). The labeling on DailyMed is presented in several formats (e.g., HTML, PDF, XML) to offer multiple choices to the user.

The National Library of Medicine (NLM), a National Institutes of Health (NIH) institute, provides DailyMed to the public. Additional information about medicines is available on NLM's MedlinePlus Web site.


Differences Between Labeling on DailyMed and FDA-Approved Labeling
The "in use" labeling on DailyMed may not be identical to the most recent FDA-approved labeling available at Drugs@FDA or the labeling distributed with products. The contents of the "in use" labeling on DailyMed may not have been verified by FDA. Note: NLM does not review any SPL content prior to publication. Visit the following sites for the most current labeling approved by the FDA for human use in the United States:

  • Drugs@FDA for prescription drug products, many therapeutic biological products, and nonprescription drugs and biological products
  • Biologics Products & Establishments for allergenic products; blood and blood products; cellular and gene therapy products; plasma derivatives; and vaccines

Also see the following FDA websites for more information about FDA-regulated products: animal drugs, dietary supplements, cosmetics, devices, and medical foods.

Drugs marked "unapproved" on DailyMed have not been approved by the FDA and have not been evaluated by FDA for their safety and effectiveness (additionally, their labeling has not been approved by the FDA). For more information, see Unapproved Drugs.