Over-the-counter drug · OTC MONOGRAPH DRUG
TopCare Calaclear NDC 36800-267
pramoxine hydrochloride and zinc acetate lotion · Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL · Lotion · Topical · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-267-96 | 36800026796 | 177 mL in 1 CONTAINER (36800-267-96)Marketed from Jul 16, 2019 |
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)
- TopCare Calaclear
- Generic name (nonproprietary)
- pramoxine hydrochloride and zinc acetate lotion
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mLZinc acetate — 1 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- TOPCO ASSOCIATES LLC
- 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 36800-267_0ccb3e8a-3d01-1364-e063-6294a90a70e8SPL ID 0ccb3e8a-3d01-1364-e063-6294a90a70e8SPL set ID 8dce8817-b905-4064-e053-2995a90a071eRxCUI 1234546UNII 88AYB867L5, FM5526K07A
- 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
N436800026796followed by a unit qualifier and the quantityPackage 36800-0267-96. 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)
Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor 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 |
|---|---|---|---|---|
| insect bite relief 01menthol | Menthol 1 g/100mL | SprayTopical | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 82953-011 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-329 |
| TrueLipids Relieve and Protect CL MDwhite petrolatum | Petrolatum 50 g/100g | OintmentTopical | Claridei Laboratories, Inc. | 61387-254 |
| Tenderphorskin protectant | Petrolatum 44.28 g/100g | OintmentTopical | GERI-GENTLE CORPORATION | 69771-014 |
| Aveeno Calm Plus Restore Skin Therapy Balmcolloidal oatmeal | Oatmeal 10 mg/g | CreamTopical | Kenvue Brands LLC | 69968-0755 |
| Petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Perrigo Direct, Inc | 75981-069 |
| Calamineferric oxide red | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-248 |
| Minoxidil Hair Growth Oil | Minoxidil 10 g/100g; Phenoxyethanol .8 g/100g | OilCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-327 |
| Vitamin A and Dpetrolatum | White petrolatum 934 mg/g | OintmentTopical | Aldermed Inc. | 87236-006 |
| Petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | The Kroger Co. | 30142-069 |
| TN Dickinsons Witch Hazel Astringentwitch hazel | Witch hazel 86 g/100mL | LiquidTopical | Dickinson Brands Inc. | 52651-001 |
| Crash Creamwhite petrolatum | White petrolatum 50 g/100g | OintmentTopical | Claridei Laboratories | 61387-251 |
| Dabur Zinc Oxide 3.8%zinc oxide | Zinc oxide 3.8 g/100g | OintmentTopical | Dabur India Limited | 68747-8020 |
| Nuvalu Petroleum Baby Fresh Scentwhite petrolatum | Petrolatum 99.9 g/100g | JellyTopical | JC SALES | 72520-203 |
| Royal Creamy Petroleum Jellypetrolatum jelly | Petrolatum 30 g/100g | JellyTopical | Mission Series Inc. dba Prestige Beauty Care | 73597-012 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-328 |
| XIMONTH Bee Venom Wart Remover Patchglycerin | Melaleuca alternifolia (Tea tree) leaf oil .0288 mg/144mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-010 |
| Zinc Oxide Skin Protectantzinc oxide 20% | Zinc oxide 20 g/100g | OintmentTopical | Aldermed Inc. | 87236-007 |
| TrueLipids 1% Hydrocortisone Barrier Creamhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Claridei Laboratories | 61387-252 |
| Walgreens Baby Healingpetrolatum | Petrolatum 410 mg/g | OintmentTopical | Walgreens Company | 0363-0079 |
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