CVS Calamine Plus Roll On
- Product NDC
- 51316-420
- 11-digit product format
- 513160420
- Labeler code
- 51316
- Product ID
- 51316-420_5cba0a46-e0c1-2601-e063-6394a90a0ca9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- zinc oxide, pramoxine hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- CVS Pharmacy
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-30
- Substance
- ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 80; 10 mg/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CVS Calamine Plus Roll On
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 80 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-420-97 | 51316042097 | 74 mL in 1 BOTTLE, PLASTIC (51316-420-97) | 74 ml | 2026-09-30 | No | No | Current |