About the DrugInserts.com FDA Product Label and Package Insert Database

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DrugInserts.com formats and delivers product label and package insert information for tens of thousands of drugs. We deliver FDA drug information directly via our websites and indirectly via third-party licensees of our Drug Information Delivery System. Our customers include medical professionals and researchers, top-tier health and mental health information providers, and financial analysts covering the pharmaceutical and healthcare industries.

Our Medication Information

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. This HL7 data standard has been adopted by the FDA as its primary mechanism for the exchange of formatted health product information.

Our medication information, sourced directly from the FDA repository, is transformed from machine-portable XML into a human readable web page, rendered with improved formatting and paginated for readability — but it is not otherwise modified with regard to medical content.

To create our database of FDA approved product labels and inserts, we begin with the current database of all SPL drug information from FDA and then run through each one to exclude:

  1. homeopathic products,
  2. veterinary products,
  3. all older entries for a specific drug from the same manufacturer

The last exclusion listed above ensures that we carry only the most up-to-date revision for a given combination of medication and manufacturer.

This process is automated and is based entirely on the date, category and manufacturer information contained within the records themselves: no human input is involved in the decision of which records to list.

Every medication information entry includes an effective/last revision date, together with full details of the company providing that information to the FDA.

Limitations

The quality of information provided on this site depends directly on the quality of what was originally provided in XML form to the FDA by the manufacturer. Unfortunately, many submissions by drug manufacturers suffer from incompleteness, incorrect formatting, formally invalid XML, or all three, and this may result in anomalies in the final human readable web page which range from poor visual presentation (e.g., inappropriate line breaks) to something approaching gibberish (e.g., incorrectly repeated or out of order sentences). While the industry continues to work to improve the quality of information supplied to the FDA, users of SPL data should be vigilant for these problems and should take appropriate steps to corroborate the information. This site operates several automated filters in an attempt to exclude entirely the most badly broken XML records and the gibberish which can result, but unfortunately we are not always successful; if you should encounter faulty records on this site, please direct any questions or requests for corrections to the drug manufacturer rather than to us, as it is not possible for us to correct problems in the manufacturers’ FDA submissions ourselves.

As per the FDA guidelines on use and interpretation of SPL resources, please take note of the following standard disclaimer:

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.

Regarding homeopathy, please note that this site does not normally carry information on homeopathic products. Very occasionally, however, homeopathic products have been incorrectly categorized as ‘other medical materials,’ ‘over the counter remedies,’ etc. in the source files provided to us by the FDA. Usually, the FDA identifies such errors and removes or recategorizes these entries at a later date.

Our Customers and Purpose

Our primary customers are members of the public, medical professionals and researchers, and financial analysts focusing on the pharmaceutical and healthcare industries.

The information provided here is intended to support and complement, not replace, the relationship between patient and physician, and all medication information provided here is subject to the Limitations indicated above.

About Our Funding and Financial Backing

This site is completely free.

The database was created as a programming project by Dr Greg Mulhauser at Mulhauser Consulting, Ltd. and is now being provided as a public service. The site receives no funding or other support except for Dr Mulhauser’s time and advertisements placed by third parties — for example, via Google AdSense.

About Our Unofficial Logo

The graphic portion of our unofficial logo was created by the talented Russian artist and illustrator Dmitry Merkushin and is used under license, copyright © Depositphotos.com/Dmitry Merkushin.

Who We Are

DrugInserts.com is a service of Mulhauser Consulting, Ltd., a company registered in England no. 4455464. Registered office: 31 High Street, Haverhill, Suffolk CB9 8AD. The company is registered in the United Kingdom as a Data Controller under the Data Protection Act 1998.

This article was originally published by on and last reviewed or updated by Site Editor on .

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

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