FDA Online Label Repository

Metadata Updated: August 20, 2018

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.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date April 6, 2016
Metadata Updated Date August 20, 2018

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date April 6, 2016
Metadata Updated Date August 20, 2018
Publisher U.S. Food and Drug Administration
Unique Identifier ff9c9ee2-8c73-4142-b21f-2b694db8f783
Maintainer
openFDA
Maintainer Email
Public Access Level public
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id 1f8bc8dc-4066-4077-917a-4c92d14afad3
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
License http://opendefinition.org/licenses/odc-odbl/
Data Last Modified 2013-11-26
Program Code 009:002
Source Datajson Identifier True
Source Hash 8aac7642a8af516d2c21875bb5f4186fefda16e7
Source Schema Version 1.1

Didn't find what you're looking for? Suggest a dataset here.