Over-the-counter drug · OTC MONOGRAPH DRUG
calahist NDC 0363-9411
calamine and pramoxine hydrochloride · Pramoxine hydrochloride 10 mg/mL; Zinc oxide 80 mg/mL · Lotion · Topical · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9411-97 | 00363941197 | 177 mL in 1 BOTTLE (0363-9411-97)Marketed from Oct 16, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- calahist
- Generic name (nonproprietary)
- calamine and pramoxine hydrochloride
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mLZinc oxide — 80 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- WALGREEN COMPANY
- 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 0363-9411_079d3e20-150d-ce65-e063-6294a90af07fSPL ID 079d3e20-150d-ce65-e063-6294a90af07fSPL set ID fed45e06-cc53-fbc5-e053-6294a90a1b19RxCUI 1234532UNII 88AYB867L5, SOI2LOH54Z
- 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
N400363941197followed by a unit qualifier and the quantityPackage 00363-9411-97. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses ■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac ■ For the temporary relief of pain and itching associated with ■ minor skin irritations ■ rashes due to poison ivy, poison oak, or poison sumac ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites
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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