Over-the-counter drug · OTC MONOGRAPH DRUG
Quality Choice Calamine (Calamine 8% and zinc oxide 8%) NDC 63868-317
Zinc oxide 160 mg/mL · Lotion · Topical · Chain Drug Market Association
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-317-06 | 6386803170663868031706 | 177 mL in 1 BOTTLE, PLASTIC (63868-317-06)Marketed from Dec 12, 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)
- Quality Choice 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 Market AssociationNDC labeler code 63868
- 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 63868-317_0cf4bfe6-384e-e836-e063-6394a90ab8c3SPL ID 0cf4bfe6-384e-e836-e063-6394a90ab8c3SPL set ID 62fe653f-e861-472b-b193-4fdd9d25de8dRxCUI 617954UNII 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
N463868031706followed by a unit qualifier and the quantityPackage 63868-0317-06. 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 o poison ivy, poison oak, and poison sumac.
Excerpt only. Read the full label for complete information.
About NDC 63868-317
- What is NDC 63868-317?
- 63868-317 is the product NDC for Quality Choice Calamine, Zinc oxide 160 mg/mL lotion, listed with the FDA by Chain Drug Market Association. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quality Choice Calamine (Calamine 8% and Zinc Oxide 8%).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- Chain Drug Market Association, NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quality Choice Calamine?
- 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 |
|---|---|---|---|---|
| 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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