FDA Online Label Repository

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U.S. Department of Health and Human Services

FDA Online Label Repository

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Please be aware of the following when using information from this Web site:

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.

The device labeling and other device-specific information on this website have been voluntarily submitted to the FDA by device manufacturers. FDA has not reviewed this information prior to posting on this website. The device labeling has been reformatted to make it easier to read but its content has not been altered nor verified by FDA. The device labeling on this website may not be the labeling on currently distributed products.

Proprietary Name Search NDC Number Search
Active Ingredient Search Application Number or Regulatory Citation Search
Company Search Proprietary Name and Company Search

Search for Labels on DailyMed

The labels are also available on the National Library of Medicine's DailyMed web site. You can search for labels by drug name and link to the Library’s information resources about marketed drugs.

Download All Labels

Health information suppliers and others can download all of the electronic files companies have submitted from the National Library of Medicine’s Download Labels site.

Additional Resources

Information about animal and human drug products can be found on these FDA Web pages:

Send questions and comments to the SPL Coordinator at spl@fda.hhs.gov

Food and Drug Administration