I am looking for OTC Labelling information and was curious how I might be able to use the information in my applications since it says the data is not for clinical use.

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    I can't explain the rationale of the disclaimer but would suggest you look at NIH dailymed which I believe is more tried and true so to speak Oct 20, 2015 at 23:12

2 Answers 2


openFDA is not for clinical use since it is a research project still in beta. Additional details can be found on the about page:


If you need labeling information for clinical use now, I'd use dailymed as skram suggests.


Basically, the data can't be considered "complete" and thus trustworthy.

Most of the information contained there comes from sources that need to handle their data really carefully. Consider drug adverse events of device recalls. After a report of one of this events an investigation may follow. Protected health information (patient or hospital names, for example) must be kept safe. Once the investigation resolves this information is sanitized or de-identified and then made available. This means that you don't get a "state-of-the-art" snapshot of FDA's complete knowledge, but a small fraction, that they can make publicly available in a safe way for all parties involved.

They provide what they can and want you to use this data for research purposes. As stated in their challenges the goal (of the challenge, but ultimately of the platform) is to give you

high-value public-access data [...] in developer and consumer-friendly standards, and make it available via a public-access portal that enables developers to quickly and easily use it in applications

with the hope that you (as a researched or developer) will create something that will benefit the general public

the direct beneficiaries are expected to be the public, it’s possible that an outcome could be useful for FDA work. For example, the community initially developed the code to connect the R library (a group of open source statistical analysis packages) to openFDA

But they are not going to provide you with a "production" environment with access to all the FDA information. If you work in a clinical environment and you want to know if a device has been involved in a recall by FDA, you can't use openFDA. You probably will have to use other mechanisms, like Maude, which will give you reliable (meaning, as updated as it can be for a real clinical environment in which patients are involved) data.

See this related question. Sometimes it takes a couple months for data to get published.

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