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

Additional Info

Field Value
Maintainer openFDA
Last Updated March 8, 2021, 03:01 (EST)
Created March 8, 2021, 03:01 (EST)
Identifier ff9c9ee2-8c73-4142-b21f-2b694db8f783
Issued 2013-11-26
Modified 2013-11-26
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
encoding utf8
harvest_url http://catalog.data.gov/dataset/309c8678-fcfb-45fe-ab60-09277b8d5326
landingPage http://labels.fda.gov/
programCode {009:002}
publisher U.S. Food and Drug Administration
resource-type Dataset
source_datajson_identifier true
source_hash bb3f9b1d20a307d9ec36175bdfe7047121af76b9
source_schema_version 1.1