FDA’s Labeling Resources for Human Prescription Drugs
For Industry
FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling:
- Contains a summary of the essential scientific information needed for the safe and effective use of the drug; and
- Includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling.
For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs see video.
If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines.
- DailyMed: NIH’s labeling tool designed to search over 140,000 labeling documents for prescription drugs, nonprescription drugs, animal drugs, and other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods).
- Drugs@FDA: Includes information about drugs approved for human use in the United States:
- Drug information,
- Regulatory history,
- Most recent FDA-approved Prescribing Information and patient labeling, and
- Reviews by FDA staff that evaluate the safety and effectiveness of the drug.
- FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results. For the similarities and differences between FDALabel and DailyMed see Slides 42-44 in the Prescription Drug Labeling Updates presentation. For recommendations on how to navigate FDALabel and other databases, see 2024 video.
- Medication Guides: Includes Medication Guides approved by the Center for Drug Evaluation and Research
- Drug Safety-Related Labeling Changes Database: Includes recent updates to safety information in labeling including labeling changes from efficacy supplements and labeling supplement approvals. These labeling changes include changes:
- Recommended by the FDA or initiated by companies, and
- Required by the FDA under Section 505(o)(4) of the FD&C Act (safety labeling changes)].
- Established Pharmacologic Class database includes a list of EPC phrases for approved active moieties. For more EPC resources, see the “Highlights of Prescribing Information” heading on the publicly available Prescribing Information Resources website.
- Pediatric Labeling Information Database: Includes labeling recently updated with pediatric use information
- Product Title Examples: Examples of product titles in the Highlights of Prescribing Information of approved labeling consistent with the product title requirements (21 CFR 201.57(a)(2)) and the recommendations in the draft guidance for industry: Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products - Content and Format (July 2018) (when final this guidance will represent the FDA’s current thinking on this topic).
The current labeling (also referred to as the in use labeling) submitted by companies to the FDA (e.g., labeling that appears on DailyMed and FDALabel) may differ from the last FDA-approved labeling (e.g., labeling that appears on Drugs@FDA) because the current labeling may contain unapproved changes:
- Minor changes (e.g., editorial changes such as a change to the distributor’s name and location) in an annual reportable change, or
- Moderate changes (e.g., adding or strengthening a warning or adverse reaction) in a “Changes Being Effected” (CBE) labeling supplement that is undergoing FDA review.
In contrast, labeling that appears on Drugs@FDA includes human prescription drug labeling approved by the Center for Drug Evaluation and Research at the FDA.
- Accelerated Approval Database includes a list of CDER- and CBER-regulated drugs with accelerated approval (AA) indications and provides information regarding the status of the AA indication (e.g., verified clinical benefit, ongoing studies, AA indication withdrawn).
- Animal Rule Approvals database includes a list of CDER-regulated products with indications approved under the Animal Rule. Such indications are for the reduction or prevention of serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances.
- Biosimilar Product Information database includes a list and information about all FDA-licensed biosimilar products and interchangeable biosimilar products in the U.S.
- CBER’s Novel Biological Products includes a list of CBER’s new biological product approvals and other noteworthy approvals.
- CDER’s Novel Drugs and Biological Products database includes information about all CDER-approved new molecular entities and new biological products approved since 2015 (e.g., approval date, links to the product’s Drugs@FDA webpage).
- CDER’s Novel Drugs and Biological Products webpage includes information about all CDER-approved new molecular entities and new biological products approved from 1985 to 2022.
- Deemed BLA Database includes a list of applications for biological products under section 505 of the Federal Food, Drug, and Cosmetic Act was deemed to be a license for the biological product under section 351 of the Public Health Service Act.
- Drug Safety Communications contains the most recent Drug Safety Communications from FDA.
- Drug-Specific Information including drug-specific postmarketing safety information
- Drug Trials Snapshots (DTS) provides information about the diversity of participants in clinical trials that supported the original approval of the drug. DTS provides information about the percentage of women and men, racial groups, ethnic groups, and age groups in these clinical trials. DTS also provides data on the safety and efficacy of these groups in the clinical trials.
- Emergency Use Authorization includes EUA fact sheets (for healthcare professionals and for patients, caregivers, and parents) for the emergency use of vaccines, drugs, therapeutic products, and medical devices for the treatment or prevention of COVID-19.
- National Drug Code (NDC) Directory is a searchable online database for NDCs.
- Orange Book is a searchable online database containing FDA-approved drugs with therapeutic equivalence evaluations based on safety and effectiveness under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information.
- Purple Book is a searchable online database that contains information about biological products licensed by the FDA under the Public Health Service Act.
- REMS@FDA is a searchable database that contains FDA-approved Risk Evaluation and Mitigation Strategies (REMS). REMS are drug safety programs that the FDA can require for certain prescription drugs with serious safety concerns to help ensure the benefits of the drug outweigh its risks.
- United States Pharmacopeia-National Formulary Resources contains monographs for drug products and other legally marketed articles in the United States (e.g., medical devices). These resources require a USP subscription.
- Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal FD&C Act (final guidance)
- Importation of Prescription Drugs (final rule) - 85 FR 62094
- Importation of Prescription Drugs Final Rule Questions and Answers (final guidance)
- Promotional labeling resources for human prescription drugs, and
- Labeling resources for other FDA-regulated products such as nonprescription drug products ("over-the-counter" drugs), medical devices, homeopathic products, dietary supplements, foods, cosmetics, tobacco, or animal drugs.
Sub-Topic Paragraphs