How to get NDC Number for Cosmetics

Can I assign NDC Number to a Cosmetic?

It is a common misconception that cosmetics with NDC number is eligible for Medicare reimbursement. NDC Number (National Drug Code) is only for drugs, it is not for cosmetics. Assignment of NDC number to cosmetics and other non-drug products is prohibited. Cosmetics and other non-drug products with NDC Labeler code on its label will considered as misbranded and FDA may take regulatory action.

Products marketed as cosmetic in other countries may consider as drugs in the USA. Sunscreen with SPF, antiseptic hand sanitizer, anti-dandruff shampoo, acne creams etc. are examples of products which are regulated by FDA as drug.

Cosmetics marketed with drug claims like anti-aging, anti-wrinkle etc. are considered as misleading claims and may consider as misbranded.

Drug products listed with FDA can be find at National drug code directory and also at DailyMed website .

For more information about how to get NDC number / Labeler code assignment or to request an NDC labeler code for your establishment please contact us at info@fdahelp.us

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