Over-the-counter drug · OTC MONOGRAPH DRUG
CVS Calamine Plus Roll On (Zinc oxide, pramoxine hydrochloride) NDC 51316-420
Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-420-97 | 51316042097 | 74 mL in 1 BOTTLE, PLASTIC (51316-420-97)Marketed from Sep 30, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- CVS Calamine Plus Roll On
- Generic name (nonproprietary)
- zinc oxide, pramoxine hydrochloride
- Active ingredients
- Zinc oxide — 80 mg/mLPramoxine hydrochloride — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- CVS PharmacyNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 51316-420_5cba0a46-e0c1-2601-e063-6394a90a0ca9SPL ID 5cba0a46-e0c1-2601-e063-6394a90a0ca9
- Pharmacologic class
- Copper Absorption Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451316042097followed by a unit qualifier and the quantityPackage 51316-0420-97. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51316-420
- What is NDC 51316-420?
- 51316-420 is the product NDC for CVS Calamine Plus Roll On, Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CVS Calamine Plus Roll On (Zinc oxide, pramoxine hydrochloride).
- What is the active ingredient?
- Zinc oxide, Pramoxine hydrochloride.
- Who is the labeler?
- CVS Pharmacy, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CVS Calamine Plus Roll On?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 016
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Colloidal oatmeal | Oatmeal 10 mg/g | CreamTopical | Meijer, Inc. | 79481-6601 |
| Gold Bond Eczema Relief Medicated Hand Creamcolloidal oatmeal | Oatmeal 2 g/100g | CreamTopical | Chattem, Inc. | 41167-0668 |
| Venrockrosemary oil | Rosmarinus officinalis (Rosemary) leaf oil 55 g/100g; Biotin .001 g/100g | OilTopical | Guangzhou Oupeng Cosmetics Co., Ltd | 85772-0007 |
| First Aid Beauty FAB Ultra Repair Body Skin Protectantcolloidal oatmeal | Oatmeal .5 g/100g | LotionTopical | The Procter & Gamble Manufacturing Company | 69423-726 |
| AHHH Bite Reliefsodium bicarbonate | Sodium bicarbonate 5 g/25g | GelTopical | 78271 | 78271-041 |
| Vitacilina Bebe Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | Taisho Pharmaceutical California Inc. | 81929-002 |
| Witch Hazel | Witch hazel 842 mg/mL | LiquidTopical | TOP CARE (Topco Associates LLC) | 36800-039 |
| First Aid Beauty Face and Body Bestsellers Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-911 |
| Skin Protectant with 33% Petrolatum Advance Moisturizing Creampetrolatum | Petrolatum 33 g/100g | CreamTopical | Aldermed Inc. | 87236-011 |
| Theriac Advanced Healinglanolin | Lanolin 350.8 mg/g | OintmentTopical | Sheffield Pharmaceuticals LLC | 11527-325 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-060 |
| Sarnacolloidal oatmeal | Oatmeal 20 mg/mL | LotionTopical | Crown Laboratories, Inc. | 0316-0256 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-912 |
| ProCure Zinc Oxidezinc oxide | Zinc oxide 20 g/100g | OintmentTopical | Twin Med LLC | 55681-017 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-061 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| Desitin Maximum Strength Zinc Oxide Diaper Rashzinc oxide | Zinc oxide 400 mg/g | PasteTopical | Kenvue Brands LLC | 69968-0396 |
| Hydrophor | Petrolatum 42 g/100g | OintmentTopical | Akron Pharma Inc. | 71399-5101 |
| Attitude Diaper Cream Zinc Unscentedzinc oxide | Zinc oxide 15 g/100g | StickTopical | 9055-7588 Quebec Inc. (Attitude) | 61649-260 |
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