labels.fda.govFDA Label Search

FDA Online Label Repository Quick Links: 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: 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 spl@fda.hhs.gov Food and Drug Administration - - This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco.Links on this page: Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players . Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies / Privacy U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Vulnerability Disclosure Policy Links on this...