FDA Online Label Repository
type: Dataset
description: 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.
issued: 2021-02-25
modified: 2013-11-26
contact point: Organization
  fn: openFDA
keyword: AmeriGEO
keyword: AmeriGEOSS
keyword: CKAN
keyword: GEO
keyword: GEOSS
keyword: National
keyword: North America
keyword: United States
keyword: community-health
keyword: drug
keyword: fda
keyword: label
keyword: label-repository
keyword: labeling
keyword: labels-fda-gov
theme: {FDA}

Zip File
type: Distribution
description: ucm240580.htm
format: ZIP
issued: 2020-11-10T16:19:20.390709
modified: 2025-09-24T21:38:24.793009
access URL: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm
media type: application/zip

US Migrating
type: Agent