Over-the-counter drug · OTC MONOGRAPH DRUG
Freskaro Calamine Plus (Zinc oxide lotion) NDC 82645-420
Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · Pharma Nobis, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82645-420-96 | 8264504209682645042096 | 177 mL in 1 BOTTLE, PLASTIC (82645-420-96)Marketed from Apr 15, 2026 |
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)
- Freskaro Calamine Plus
- Generic name (nonproprietary)
- zinc oxide lotion
- Active ingredients
- Zinc oxide — 80 mg/mLPramoxine hydrochloride — 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 82645-420_4f85c89b-114c-d84d-e063-6294a90aa32aSPL ID 4f85c89b-114c-d84d-e063-6294a90aa32aSPL set ID 4f85bdc7-8fed-f1f5-e063-6394a90a6358RxCUI 1234532UNII SOI2LOH54Z, 88AYB867L5UPC 0382645420963
- 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
N482645042096followed by a unit qualifier and the quantityPackage 82645-0420-96. 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.
About NDC 82645-420
- What is NDC 82645-420?
- 82645-420 is the product NDC for Freskaro Calamine Plus (zinc oxide lotion), Zinc oxide 80 mg/mL; Pramoxine hydrochloride 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?
- Freskaro Calamine Plus (Zinc oxide lotion).
- What is the active ingredient?
- Zinc oxide, Pramoxine hydrochloride.
- 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 Freskaro Calamine Plus?
- 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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