NDC Number for Cosmetics
Cosmetic products do NOT need an NDC number. NDC numbers are assigned to drug products only. However, some cosmetic products may be classified as drugs — LMG explains the distinction.
Do Cosmetics Need an NDC Number?
Cosmetics do not need an NDC (National Drug Code) number. NDC numbers are assigned to drug products only. A pure cosmetic product — one that does not contain drug active ingredients and makes no drug claims — does not require FDA drug registration or an NDC number.
However, some products that appear to be cosmetics may actually be regulated as drugs (or as both a drug and a cosmetic) if they contain drug active ingredients or make drug claims. Examples include: sunscreen (SPF claim = drug), anti-dandruff shampoo (pyrithione zinc = drug), whitening toothpaste with fluoride (drug), and anti-acne products (drug).
Under MoCRA 2022, cosmetic facility registration and product listing are required — but this is separate from drug registration and does not involve NDC numbers.
If you are unsure whether your product is a cosmetic or a drug, LMG can help you determine the correct FDA classification using our Cosmetic Drug Classifier tool.
- Pure cosmetics: No NDC number required — register under MoCRA
- Cosmetics with drug active ingredients: Require drug registration and NDC labeler code
- Example drug-cosmetics: Sunscreen (SPF), anti-dandruff, fluoride toothpaste, anti-acne products
- Use LMG’s Cosmetic Drug Classifier to determine your product’s classification
Frequently Asked Questions
Does a cosmetic product need an NDC number?
How do I know if my cosmetic product is also a drug?
What registration is required for a pure cosmetic?
Not Sure if Your Product is a Cosmetic or Drug?
Use LMG's Cosmetic Drug Classifier or contact us for expert guidance on FDA product classification.
Use the Classifier Contact Us