FDA Online Label Repository

The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked 'OTC monograph final' or OTC monograph not final' are not checked for conformance to the monograph. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.

Data and Resources

Field Value
accessLevel public
bureauCode {009:10}
catalog_@context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
catalog_@id https://healthdata.gov/data.json
catalog_conformsTo https://project-open-data.cio.gov/v1.1/schema
catalog_describedBy https://project-open-data.cio.gov/v1.1/schema/catalog.json
identifier ff9c9ee2-8c73-4142-b21f-2b694db8f783
issued 2021-02-25
landingPage http://labels.fda.gov/
license http://opendefinition.org/licenses/odc-odbl/
modified 2013-11-26
programCode {009:002}
publisher U.S. Food and Drug Administration
resource-type Dataset
source_datajson_identifier true
source_hash 15da727484dd14d3228a2355551d3b85ba1b50855b87b03b5f8ede64aaa5203c
source_schema_version 1.1
theme {FDA}
Groups
  • AmeriGEOSS
  • National Provider
  • North America
Tags
  • AmeriGEO
  • AmeriGEOSS
  • CKAN
  • GEO
  • GEOSS
  • National
  • North America
  • United States
  • community-health
  • drug
  • fda
  • label
  • label-repository
  • labeling
  • labels-fda-gov
isopen False
license_id other-license-specified
license_title other-license-specified
maintainer openFDA
maintainer_email open@fda.hhs.gov
metadata_created 2025-09-24T21:38:24.816123
metadata_modified 2025-09-24T21:38:24.816133
notes The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked 'OTC monograph final' or OTC monograph not final' are not checked for conformance to the monograph. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.
num_resources 1
num_tags 15
title FDA Online Label Repository