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FDA Drug Labels

Included herein, you will find high quality information about marketed drugs via DailyMed. This information includes FDA labels (package inserts) and provides the public with a standard, comprehensive, up-to-date look-up of medication content and labeling as found in medication package inserts.

Drug labeling and other information in the SPL (Structured Product Labeling) is what has been submitted by drug companies to the Food and Drug Administration (FDA) as drug listing information (See 21 CFR part 207).  The drug labeling has been reformatted to make it easier to read but its content has not been altered or verified by FDA or the National Library of Medicine (NLM).  The drug labeling reached may not be the labeling on currently distributed products or identical to the labeling that is approved.  Drugs marked "OTC monograph final" or "OTC monograph not final" are not checked for conformance to the monograph.  Drugs marked "unapproved" have not been reviewed by the FDA for safety and efficacy and their labeling has not been approved.  For more information about unapproved drugs, visit Enforcement Activities by FDA.

Other information about drugs may also be available.  The NLM regularly processes data files uploaded from the FDA's system and provides this information for public use.  Additional information about medicines is available on MedlinePlus.

At the present time this applet does not contain a complete listing of labels for approved prescription drugs. Currently this applet contains information about 147410  labels.

Note: Over the counter drug companies just started sending the SPL (electronic labels) in June 2009. Therefore, not all electronic labels have been received.

For more comprehensive information about drugs, please visit our Mobile Drug Guide and our HIV/AIDS Mobile Drug Guide.

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