Tools and directories

Are you a drug? A check

Updated October 2026

On this page5

Nine questions If any answer is yes If every answer is no Re-run it when anything changes References

A short check to run before printing anything. It is not a legal determination about your product; it is a way of finding out whether you need one.

Nine questions

1. Does any label, page, sign or post say the product treats, relieves, prevents or protects against anything?

2. Do the words chapped, cracked or dry appear anywhere in connection with it?

3. Do the words heal, repair, restore or soothe appear?

4. Does it claim protection from wind, cold or sun?

5. Does it carry an SPF number, or a sunscreen active?

6. Does it reference cold sores, blisters or any condition?

7. Does the formula contain an ingredient from the 347.10 list at or above its monograph minimum, petrolatum at 30 percent or more, cocoa butter or mineral oil at 50 or more, lanolin at 12.5 or more?

8. Do your product name or range name describe an outcome rather than a flavor or a material?

9. Do reviews or testimonials you have chosen to display make any of the above claims on your behalf?

If any answer is yes

You are looking at the drug side, and the consequences are establishment registration, an NDC labeler code, annual drug listing, Drug Facts labeling and cGMP under 21 CFR 210 and 211, none of which has a small-business exemption.

Two responses. Formulate and label to the monograph and accept those obligations, or remove what triggered the answer.

Question 7 is the one people are caught by, because it is about the formula rather than the words.

If every answer is no

You are on the cosmetic side. The obligations are cosmetic labeling, MoCRA registration and listing where it applies, and safety substantiation, which applies at any size.

Re-run it when anything changes

A new flavor, a reformulation, a new marketplace listing, a seasonal campaign, a new person writing your social posts.

The common failure is not a decision to become a drug. It is a product that was a cosmetic when it was designed and is being sold as something else eighteen months later.

References

21 CFR 347.10, Skin protectant active ingredients. A closed list at fixed concentrations, including allantoin 0.5–2%, cocoa butter 50–100%, dimethicone 1–30%, glycerin 20–45%, hard fat 50–100%, lanolin 12.5–50%, mineral oil 50–100%, petrolatum and white petrolatum 30–100%. ecfr.gov

21 CFR 347.3, Definitions. "Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called ‘lip balm.’" ecfr.gov

US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Intended use, established by claims, is what decides. fda.gov

FDA drug establishment registration and drug listing: an NDC labeler code, product listing, and annual renewal between 1 October and 31 December, required of anyone manufacturing, repacking or relabeling an OTC drug product. fda.gov

21 CFR Parts 210 and 211, Current Good Manufacturing Practice for finished pharmaceuticals, which apply to OTC monograph drug products with no exemption based on the size of the business. ecfr.gov

Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.