Over-the-counter drug · OTC MONOGRAPH DRUG
Clear Anti-Itch (Pramoxine hcl, zinc acetate) NDC 11344-812
Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL · Lotion · Topical · Nice-Pak Products, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)11344-812Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11344-0812Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11344-812-30 | 1134408123011344081230 | 177 mL in 1 BOTTLE, PLASTIC (11344-812-30)Marketed from Jul 29, 2024 |
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)
- Clear Anti-Itch
- Generic name (nonproprietary)
- pramoxine hcl, zinc acetate
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mLZinc acetate — 1 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Nice-Pak Products, LLCNDC labeler code 11344
- 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 11344-812_5b87a395-fb78-70b0-e063-6394a90a8839SPL ID 5b87a395-fb78-70b0-e063-6394a90a8839
- 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
N411344081230followed by a unit qualifier and the quantityPackage 11344-0812-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 11344-812
- What is NDC 11344-812?
- 11344-812 is the product NDC for Clear Anti-Itch, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL lotion, listed with the FDA by Nice-Pak Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clear Anti-Itch (Pramoxine HCl, Zinc acetate).
- What is the active ingredient?
- Pramoxine hydrochloride, Zinc acetate.
- Who is the labeler?
- Nice-Pak Products, LLC, NDC labeler code 11344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clear Anti-Itch?
- 9 other product NDCs are listed under this name. See all Clear Anti-Itch NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clear Anti-Itch products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clear Anti Itchpramoxine hcl, zinc acetate lotion | Pramoxine HCl 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | H E B | 59640-218 | 59640-0218-30 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-245 | 83324-0245-06 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Retail Business Services, LLC | 72476-218 | 72476-0218-30 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Old East Main Co. | 55910-218 | 55910-0218-30 |
| Clear Anti Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Topco Associates LLC | 36800-218 | 36800-0218-30 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Meijer, Inc. | 41250-218 | 41250-0218-30 |
| Clear Anti Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Better Living Brands, LLC | 21130-952 | 21130-0952-30 |
| Clear Anti-Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Perrigo Direct, Inc | 75981-218 | 75981-0218-30 |
| Clear Anti Itchpramoxine hcl, zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | United Natural Foods, Inc. dba UNFI | 41163-099 | 41163-0099-30 |
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 |
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