Cosmetic vs. Drug Classifier
The claims on your label can quietly turn a cosmetic into a drug in FDA’s eyes — triggering an entirely different set of registration, labeling, and manufacturing requirements. This tool asks about your product’s intended use and claims, then classifies it as a cosmetic, an OTC drug, or both, based on FDA’s official criteria under the FD&C Act.
FD&C Act Criteria
Instant Classification
Avoid Misbranding Risk
Question 1 of 4
What type of product do you have?
FD&C Act §201(i) & §201(g)
Select the category that best describes your product:
Some categories are automatically regulated as OTC drugs by FDA — regardless of how they are marketed. If your product belongs to one of these, you will receive an immediate result.