FDA Online Label Repository
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.
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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 LabelsHealth information suppliers and others can download all of the electronic files companies have submitted from the National Library of Medicine’s Download Labels site.
Information about animal and human drug products can be found on these FDA Web pages:
- Animal and Veterinary Products, where information about animal drugs products is available.
- Drugs @ FDA, where information about FDA-approved human brand name and generic drugs as well as therapeutic biological products is available.
- Biologics Products and Establishments, where information about vaccines, allergenics, and blood products is available.
- Office of Nonprescription Products, where information about human OTC drug products is available.
- Unapproved Drugs: Drugs Marketed in the United States that Do Not Have Required FDA Approval, where information about unapproved human drugs products is available.
- Unapproved Drugs: Drugs Marketed in the United States that Do Not Have Required FDA Approval, where information about unapproved animal drugs products is available.
- Downloadable SPL data
Send questions and comments to the SPL Coordinator at firstname.lastname@example.org
Food and Drug Administration