Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine (Calamine, pramoxind hcl) NDC 75981-336
Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · Perrigo Direct, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75981-336-30 | 7598103363075981033630 | 177 mL in 1 BOTTLE, PLASTIC (75981-336-30)Marketed from Sep 8, 2016 |
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, pramoxind hcl
- Active ingredients
- Ferric oxide red — 80 mg/mLPramoxine hydrochloride — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Perrigo Direct, IncNDC labeler code 75981
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 75981-336_4b312a63-f96b-3dcb-e063-6394a90a0815SPL ID 4b312a63-f96b-3dcb-e063-6394a90a0815SPL set ID 54a20ec9-ab86-4410-af94-e04393e9d4b3RxCUI 1234532UNII 1K09F3G675, 88AYB867L5
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
N475981033630followed by a unit qualifier and the quantityPackage 75981-0336-30. 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 for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac dries the oozing and weeping of poison: -ivy -oak -sumac
Excerpt only. Read the full label for complete information.
About NDC 75981-336
- What is NDC 75981-336?
- 75981-336 is the product NDC for Calamine, Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Perrigo Direct, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calamine (Calamine, Pramoxind HCl).
- What is the active ingredient?
- Ferric oxide red, Pramoxine hydrochloride.
- Who is the labeler?
- Perrigo Direct, Inc, NDC labeler code 75981. 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 and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Pharma Nobis, LLC | 82645-418 | 82645-0418-96 |
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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Aveeno Baby Eczema Therapy Moisturizingoatmeal | Oatmeal 10 mg/mL | CreamTopical | Kenvue Brands LLC | 69968-0923 |
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