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.
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|