Over-the-counter (OTC)

An over-the-counter drug is a medicine that may be sold without a prescription because the FDA has found it safe and effective for consumers to use on their own.

Products reach this status either through an approved application or by conforming to an FDA monograph that sets permitted ingredients, doses and labeling for a category such as pain relievers or antacids. The label carries a standardized Drug Facts panel listing the active ingredient, uses, warnings and directions. That panel is a regulatory signal that the product is a drug.

CBD is not an approved active ingredient for any over-the-counter drug category, and no monograph includes it. Some topical products pair CBD with a monograph active such as menthol or lidocaine and carry a Drug Facts panel for that ingredient; any uses stated apply to the monograph active, not to the CBD. A product that presents CBD itself with drug-style uses is making claims the framework does not support.