Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine Phenolated Topical Suspension (Calamine and zinc oxide and phenol) NDC 82645-921
Zinc oxide 160 mg/mL; Phenol 10 mg/mL · Lotion · Topical · Pharma Nobis, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82645-921-96 | 8264509219682645092196 | 177 mL in 1 BOTTLE, PLASTIC (82645-921-96)Marketed from Nov 16, 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)
- Calamine Phenolated Topical Suspension
- Generic name (nonproprietary)
- calamine and zinc oxide and phenol
- Active ingredients
- Zinc oxide — 160 mg/mLPhenol — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Pharma Nobis, LLCNDC labeler code 82645
- 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 82645-921_0d6ccb8f-d9bf-28e6-e063-6294a90a8a87SPL ID 0d6ccb8f-d9bf-28e6-e063-6294a90a8a87SPL set ID e42fbdcc-3291-7761-e053-2995a90a7172RxCUI 991369UNII SOI2LOH54Z, 339NCG44TVUPC 0010939147332, 0087701400674
- 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
N482645092196followed by a unit qualifier and the quantityPackage 82645-0921-96. 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 and temporarily 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.
About NDC 82645-921
- What is NDC 82645-921?
- 82645-921 is the product NDC for Calamine Phenolated Topical Suspension, Zinc oxide 160 mg/mL; Phenol 10 mg/mL lotion, listed with the FDA by Pharma Nobis, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calamine Phenolated Topical Suspension (Calamine and Zinc Oxide and Phenol).
- What is the active ingredient?
- Zinc oxide, Phenol.
- Who is the labeler?
- Pharma Nobis, LLC, NDC labeler code 82645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calamine Phenolated Topical Suspension?
- 1 other product NDC are listed under this name. See all Calamine Phenolated Topical Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calamine Phenolated Topical Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calamine Phenolated Topical Suspensioncalamine and zinc oxide and phenol | Zinc oxide 160 mg/mL; Phenol 10 mg/mL | LotionTopical | Humco Holding Group, Inc | 0395-0407 | 00395-0407-96 |
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 |
|---|---|---|---|---|
| Barrier Balmcolloidal oatmeal balm | Oatmeal 1 g/100g | SalveTopical | Tubby Todd | 73088-305 |
| Earthmed Lip Balm Pineappleallantoin | Allantoin .045 g/4.455g | SalveTopical | Earthmed LLC | 82876-988 |
| Welmedix HomeCare PRO Fragile Skin Protectantpetrolatum | Petrolatum 42 g/100g | OintmentTopical | Welmedix LLC | 24330-413 |
| Petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | H E B | 37808-015 |
| Pure Petrolatum Jellypetrolatum | Petrolatum 100 g/100g | JellyTopical | MY IMPORTS USA LLC | 51628-4600 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
| Dermatitis Face Balmcolloidal oatmeal | Oatmeal 5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-121 |
| McKesson Skin Protectantzinc oxide | Zinc oxide 50 mg/mL | CreamTopical | McKesson Medical-Surgical Inc. | 68599-5312 |
| All Over Lavender Rosemarycolloidal oat ointment | Oatmeal 1 g/100g | OintmentTopical | Tubby Todd | 73088-303 |
| XIMONTH GLP-1 Patchesglycerin | Acetyl hexapeptide-8 amide .006 mg/30mg; Rose oil .006 mg/30mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-009 |
| Deep Renewal Broad Spectrumdimethicone, avobenzone, homosalate, and octisalate | Dimethicone 2 g/100g + 3 more ingredients | StickTopical | Blistex Inc | 10157-1170 |
| Skin Soothing Cream - Nut Freecolloidal oatmeal | Oatmeal 1 mg/g | CreamTopical | Allure Labs | 62742-4194 |
| Lavender Scent Petroleumwhite petroleum | Petrolatum 99.9 g/100g | JellyTopical | Jell Pharmaceuticals Pvt Ltd | 30400-514 |
| Witch Hazel | Witch hazel 842 mg/mL | LiquidTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-039 |
| Eczema Dermatitis Relief Balmcolloidal oatmeal | Oatmeal 5 g/100g | CreamTopical | Skinfix, Inc. | 61328-112 |
| Dovenourishing hand sanitizer sensitive skin 8hr moisturization | Alcohol 610 mg/mL | GelTopical | Conopco Inc. d/b/a/ Unilever | 64942-1996 |
| Petroleum Skin Protectantwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Pharmacy Value Alliance, LLC | 68016-069 |
| Sweet Cheeks Diaper Sprayerzinc oxide diaper paste spray | Zinc oxide 14.9 g/100g | SprayTopical | Tubby Todd | 73088-304 |
| Estrogen Estriol Cream5% estriol | Estriol 5 g/100g | CreamTopical | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 83364-026 |
| Earthmed FS massage oilallantoin | Allantoin 1 g/108.48g | OilTopical | Earthmed LLC | 82876-986 |
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