U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Requirements for All OTC Products
OTC Drug Labeling

In addition to labeling requirements specified in final monographs and the Drug Facts labeling requirements in 21 CFR 201.66, there are many other regulations in Part 201 of the CFR that pertain to OTC drug labeling.

Select here to download a list of additional regulations pertaining to OTC drug labeling.

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This list may seem long, but you should review it to have a better understanding of the regulations surrounding Drug Facts labeling.
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