Over-the-counter drug · OTC MONOGRAPH DRUG
Premiere Value Calamine NDC 68016-413
calamine 8% and zinc oxide 8% · Zinc oxide 160 mg/mL · Lotion · Topical · Chain Drug Consortium
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-413-96 | 68016041396 | 177 mL in 1 BOTTLE, PLASTIC (68016-413-96)Marketed from Oct 27, 2017 |
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)
- Premiere Value Calamine
- Generic name (nonproprietary)
- calamine 8% and zinc oxide 8%
- Active ingredients
- Zinc oxide — 160 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Chain Drug Consortium
- 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 68016-413_0cf4d6ef-ff52-ecf0-e063-6394a90a9802SPL ID 0cf4d6ef-ff52-ecf0-e063-6394a90a9802SPL set ID 5c8bde5a-591d-085f-e053-2991aa0a56afRxCUI 617954UNII SOI2LOH54ZUPC 0840986012952
- 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
N468016041396followed by a unit qualifier and the quantityPackage 68016-0413-96. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Astonea Skin Protectantzinc oxide | Zinc oxide 18 mg/g | OintmentTopical | ASTONEA LABS PRIVATE LIMITED | 77338-050 |
| Pure Petrolatum Jellypetrolatum | Petrolatum 100 g/100g | JellyTopical | MY IMPORTS USA LLC | 51628-4249 |
| Petroleum with Cocoawhite petrolatum | Petrolatum 100 g/100g | JellyTopical | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-599 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Strategic Sourcing Services, LLC | 70677-1196 |
| Princess Petroleumwhite petrolatum | Petrolatum 100 g/100g | JellyTopical | Ultra Distributors Inc. | 78495-004 |
| Aquaphor Lip Protectant and Sunscreenpetrolatum, avobenzone, octinoxate, octisalate, octocrylene, oxybenzone | Petrolatum 31 g/100mL + 5 more ingredients | LotionTopical | Beiersdorf Inc | 10356-111 |
| Hydrating Healing Skin Protectantpetrolatum ointment | Petrolatum 41 g/100g | OintmentTopical | CVS Pharmacy | 59779-853 |
| Vaselineclinical care hand sanitizer lotion | Benzalkonium chloride 1.3 mg/mL | LotionTopical | Conopco Inc. d/b/a/ Unilever | 64942-1849 |
| Healing Head to Toeallantoin | Allantoin .5 g/100g | OintmentTopical | The Honest Company, Inc | 69366-508 |
| Aveeno Skin Relief Overnightdimethicone | Dimethicone 12 mg/g | CreamTopical | Kenvue Brands LLC | 69968-0488 |
| JAYSUING Liquid Wart Flatglycerin | Camellia sinensis seed oil .0006 mg/3mg | LiquidTopical | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 85060-005 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Nice-Pak Products, LLC | 11344-812 |
| Skin Protectantpetrolatum | Petrolatum 410 mg/g | OintmentTopical | Wakefern Food Corp. | 41190-180 |
| Pure Petrolatum Jellypetrolatum | Petrolatum 100 g/100g | JellyTopical | MY IMPORTS USA LLC | 51628-4246 |
| Sprayable Diaper Rash Creamzinc oxide | Zinc oxide 10 g/100mL | SprayTopical | The Honest Company, Inc. | 69366-509 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurposedimethicone | Dimethicone 10 mg/mL | CreamTopical | Cosmetique Active Production | 69625-743 |
| Desitin Multi-Purpose Healingpetrolatum | Petrolatum 713 mg/g | OintmentTopical | Kenvue Brands LLC | 69968-0494 |
| CVS Zinc Oxidezinc oxide | Zinc oxide 200 mg/g | OintmentTopical | CVS Health | 69842-065 |
| Johnsons Baby Care Essentials Gift Setzinc oxide | — | Kit | Kenvue Brands LLC | 69968-0894 |
| DCH Scarallantoin 0.5% | Allantoin .5 g/100g | GelTopical | Derma Care Research Labs, LLC | 72839-097 |
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