# CVS Calamine Plus Roll On (zinc oxide, pramoxine hydrochloride) by CVS Pharmacy: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | CVS Calamine Plus Roll On |
| Generic name | zinc oxide, pramoxine hydrochloride |
| NDC | 51316-420 |
| Labeler | CVS Pharmacy |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M016 |
| Dosage form | LOTION |
| Route | TOPICAL |
| Active ingredients | ZINC OXIDE 80 mg/mL; PRAMOXINE HYDROCHLORIDE 10 mg/mL |
| Marketing start | 2026-09-30 |
| Package configurations | 1 |

## Why this score


Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=51316-420). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.