About the OTCLabels.com FDA Medication Label and Package Insert Database
OTCLabels.com formats and delivers product label and package insert information for over the counter medicines using the national FDA database of product labels and package inserts. Our customers include members of the public, medical professionals and researchers, top-tier health information providers, and financial analysts covering the pharmaceutical and healthcare industries.
Our Medication Information
Our database comes 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.
Every medication entry includes an effective/last revision date, together with full details of the company providing that information to the FDA.
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, this site does not knowingly carry information on homeopathic products. Occasionally, however, homeopathic products have been mis-categorized in FDA source files as normally regulated over the counter medicines. 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 Baldyrgan and is used under license, copyright © Depositphotos.com/Baldyrgan.
Who We Are
OTCLabels.com was created in 2011 by Mulhauser Consulting, Ltd. to complement and broaden its existing publishing portfolio of peer-reviewed mental health information. With contributors from three continents, the flagship site CounsellingResource.com is overseen by an international advisory board of distinguished academic faculty and mental health professionals with decades of combined clinical and research experience in the US, UK, Europe and Africa.
OTCLabels.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 Site Editor on .on and last reviewed or updated by