US OTC drug monograph

What is US OTC drug monograph?

Sunscreens, anti-acne, antiperspirants and anti-dandruff products are regulated in the US as over-the-counter drugs, not cosmetics. They need a Drug Facts panel, monograph-compliant actives and an NDC listing — an entirely different route from MoCRA cosmetic listing.

At a glance

Category

Regulatory

Also known as

미국 OTC 의약품

Korean term

미국 OTC 의약품

Last reviewed

July 23, 2026

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