Over-the-counter drug · OTC MONOGRAPH DRUG
Calaclear (Pramoxine hydrochloride and zinc acetate) NDC 82645-923
Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL · Lotion · Topical · Pharma Nobis, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82645-923-96 | 8264509239682645092396 | 177 mL in 1 BOTTLE, PLASTIC (82645-923-96)Marketed from Mar 25, 1998 |
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)
- Calaclear
- Generic name (nonproprietary)
- pramoxine hydrochloride and zinc acetate
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mLZinc acetate — 1 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 82645-923_0d6cc629-bac0-1229-e063-6294a90a2610SPL ID 0d6cc629-bac0-1229-e063-6294a90a2610SPL set ID e42fccc2-1b4e-e7f3-e053-2a95a90aef39RxCUI 1234546, 1248193UNII 88AYB867L5, FM5526K07AUPC 0840986012976, 0072036987259, 0036800443402, 0681131176019, 0070038200529, 0087701400452, 0010939146335, 0041220797950, 0041415067752, 0050428290880, 0093351013645
- 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
N482645092396followed by a unit qualifier and the quantityPackage 82645-0923-96. 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)
Use 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 82645-923
- What is NDC 82645-923?
- 82645-923 is the product NDC for Calaclear, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 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?
- Calaclear (Pramoxine Hydrochloride and Zinc Acetate).
- What is the active ingredient?
- Pramoxine hydrochloride, Zinc acetate.
- 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 Calaclear?
- 1 other product NDC are listed under this name. See all Calaclear NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calaclear products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calaclearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Wal-Mart Stores, Inc. | 49035-402 | 49035-0402-96 |
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 |
| 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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