Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine (Calamine and zinc oxide) NDC 82645-418
Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL · Lotion · Topical · Pharma Nobis, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82645-418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82645-0418Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82645-418-96 | 8264504189682645041896 | 177 mL in 1 BOTTLE, PLASTIC (82645-418-96)Marketed from May 16, 2023 |
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
- Generic name (nonproprietary)
- calamine and zinc oxide
- Active ingredients
- Ferric oxide red — 80 mg/mLZinc oxide — 80 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 82645-418_52b97551-89e2-c3b8-e063-6394a90af476SPL ID 52b97551-89e2-c3b8-e063-6394a90af476SPL set ID fbcfa541-beda-06de-e053-6294a90a9298RxCUI 617954UNII 1K09F3G675, SOI2LOH54ZUPC 0382645418960
- 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
N482645041896followed by a unit qualifier and the quantityPackage 82645-0418-96. 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 of poison ivy, poison oak, and poison sumac.
Excerpt only. Read the full label for complete information.
About NDC 82645-418
- What is NDC 82645-418?
- 82645-418 is the product NDC for Calamine, Ferric oxide red 80 mg/mL; Zinc oxide 80 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 (Calamine and Zinc Oxide).
- What is the active ingredient?
- Ferric oxide red, Zinc oxide.
- 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?
- 30 other product NDCs are listed under this name. See all Calamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calaminecalamine and zinc oxide | Zinc oxide 80 mg/mL; Ferric oxide red 80 mg/mL | LotionTopical | Marie's Original Formulas LLC | 87541-435 | 87541-0435-45 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Marie's Original Formulas LLC | 87541-632 | 87541-0632-72 |
| Calaminecalamine 8%, zinc oxide 8% | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Farmacias De Similares TX LLC | 85786-703 | 85786-0703-06 |
| Calamine | Ferric oxide red 80 mg/100mL; Zinc oxide 80 mg/100mL | LotionTopical | AMERISOURCE BERGEN | 46122-809 | 46122-0809-29 |
| calaminecalamine and zinc oxide | Zinc oxide 160 mg/mL | LotionTopical | STRATEGIC SOURCING SERVICES | 70677-1316 | 70677-1316-01 |
| Calaminecalamine, pramoxine hcl | Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-053 | 83324-0053-06 |
| Calamineferric oxide red | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-248 | 83324-0248-06 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Strategic Sourcing Services, LLC | 70677-1196 | 70677-1196-01 |
| calaminecalamine and zinc oxide | Zinc oxide 160 mg/mL | LotionTopical | WALGREEN COMPANY | 0363-9410 | 00363-9410-97 |
| Calaminecalamine, pramoxine hcl | Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Amazon.com Services LLC | 72288-436 | 72288-0436-30 |
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 |
|---|---|---|---|---|
| Vitamin A Dlanolin, petrolatum | Lanolin 155 mg/g; Petrolatum 534 mg/g | OintmentTopical | Kroger Co. | 30142-022 |
| Scar Treatment Balmallantoin | Allantoin, (R)- .5 g/100g | SalveTopical | Better Planet Brands LLC | 54136-365 |
| BioBarrier Repair Eye Creamallantoin | Allantoin 1.5 g/100g | CreamTopical | Bluemercury Inc. | 72203-020 |
| Boo Boo Magic Diaper Rash Creamyzinc oxide | Zinc oxide 150 mg/mL | SprayTopical | Alboo Brands LLC | 83208-001 |
| Pure petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Old East Main Co. | 55910-069 |
| ClaraVielanolin | Lanolin 50 g/100g | CreamTopical | Gentell LLC | 61554-307 |
| Aveeno Baby Eczema Therapy Moisturizing Cream Clubtraycolloidal oatmeal | — | KitTopical | Kenvue Brands LLC | 69968-0921 |
| ChapStick Classic Spearmintwhite petrolatum | Petrolatum 450 mg/g | StickTopical | Haleon US Holdings LLC | 0573-0711 |
| Calaminecalamine, pramoxind hcl | Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Perrigo Direct, Inc | 75981-336 |
| Anubis Barcelonadmae | Glycerin .555 g/30mL + 18 more ingredients | ConcentrateTopical | ANUBIS COSMETICS SL | 83021-546 |
| ODLUMIVIE Dendrobium Restorative Maskdendrobium officinale stem | Dendrobium officinale stem 1 g/100mL | LiquidCutaneous | ODLUMIVIE | 87036-030 |
| OUHOE Lipoma Creamglycerin | Angelica sinensis root .004 mg/20mg; Carthamus tinctorius (Safflower) flower .004 mg/20mg | CreamTopical | Shantou Ouhoe Technology Co., Ltd. | 85163-007 |
| Calaclearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Wal-Mart Stores, Inc. | 49035-402 |
| procurepetrolatum | Petrolatum 1 g/g | OintmentTopical | TWIN MED, LLC | 55681-211 |
| insect bite relief 01menthol | Menthol 1 g/100mL | SprayTopical | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 82953-026 |
| Skin protectantpetrolatum | Petrolatum 410 mg/g | OintmentTopical | Nice-Pak Products, LLC | 11344-247 |
| Pure petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Rite Aid Corporation | 11822-3135 |
| Diaper Rashzinc oxide | Zinc oxide 400 mg/g | PasteTopical | The Kroger Co. | 30142-020 |
| Balmex Diaper Rashzinc oxide 11.3% | Zinc oxide 11.3 g/100g | CreamTopical | Randob Labs, LTD | 52412-285 |
| PROCURE VITAMIN A AND D Skin Protectantpetrolatum | Petrolatum 93.4 g/100g | OintmentTopical | TWIN MED, LLC | 55681-215 |
Showing 20 of 40.