Over-the-counter drug · OTC MONOGRAPH DRUG
Tinea Versicolor Treatment Bar (Clotrimazole) NDC 85398-003
Clotrimazole 10 mg/g · Soap · Topical · Beautivity LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85398-003-01 | 85398000301 | 116 g in 1 CARTON (85398-003-01)Marketed from May 12, 2025 |
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)
- Tinea Versicolor Treatment Bar
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 10 mg/g
- Dosage form
- Soap
- Route
- Topical
- Labeler
- Beautivity LLCNDC labeler code 85398
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 85398-003_5566dc99-c9b2-82de-e063-6294a90a45e5SPL ID 5566dc99-c9b2-82de-e063-6294a90a45e5SPL set ID 33612382-2f12-e9f6-e063-6394a90aaee4RxCUI 251267UNII G07GZ97H65
- Pharmacologic class
- Azole Antifungal
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
N485398000301followed by a unit qualifier and the quantityPackage 85398-0003-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 85398-003
- What is NDC 85398-003?
- 85398-003 is the product NDC for Tinea Versicolor Treatment Bar (clotrimazole), Clotrimazole 10 mg/g soap, listed with the FDA by Beautivity LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tinea Versicolor Treatment Bar (Clotrimazole).
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- Beautivity LLC, NDC labeler code 85398. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tinea Versicolor Treatment Bar?
- 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 005
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 |
|---|---|---|---|---|
| 1% ketoconazoleketoconazole | Ketoconazole 10 mg/mL | ShampooTopical | TAGRID LLC | 85384-0001 |
| 1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo | Ketoconazole 1 g/100mL | ShampooCutaneous | Fast Sold LLC | 86241-110 |
| 1236-CS Antifungal Powder (Talc Free)1236-ccantifungal powder(talc free) | Miconazole nitrate 20 mg/g | PowderTopical | Dynarex Corporation | 67777-313 |
| 2% MICONAZOLE NITRATE ANTIFUNGAL Cream | Miconazole nitrate 2 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-025 |
| 4ozmiconazole | Miconazole 1.2 g/120g | SoapTopical | Nabrace LLC | 84056-003 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | Benzoyl peroxide 5 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-026 |
| 70% Isopropyl Alcoholisopropyl alcohol | Isopropyl alcohol 70 g/100mL | LiquidTopical | IDO PHARM | 77039-010 |
| Activ-Charcoal Antifungaltolnaftate | Tolnaftate 1 g/100g | SoapTopical | HONG KONG UNORDERED TRADING CO., LIMITED | 87800-0002 |
| ADI Medical PVP-I Pouch, Foilpovidone-iodine | Povidone-iodine 10 g/100g | SolutionTopical | Asia Dynamics Inc., d/b/a ADI Medical | 83645-550 |
| Aiilo NAIL FUNGUS TREATMENTundecylenic acid 25% | Undecylenic acid .25 mg/30mL | LiquidTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-190 |
| Akin Anti-Fungalclotrimazole | Clotrimazole 10 mg/mL | SolutionTopical | Southern Sales & Service, Inc. | 69822-254 |
| AlphaTip Nail Repair Pennail repair pen | Undecylenic acid 20 g/100mL | LiquidTopical | Guangzhou Qiexiran Cosmetics Co., Ltd. | 85817-008 |
| Alveora FOOT ODOR PROBIOTICtolnaftate 1% foot odor probiotic | Tolnaftate 1 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-030 |
| Alveora NAIL FUNGUS TREATMENT | Tolnaftate 1 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-033 |
| Amerfresh Antibacterial Deodorantbenzethonium chloride | Benzethonium chloride .1 g/100g | SoapTopical | Liufangjing Biotechnology (Yangzhou) Co., Ltd | 85420-002 |
| Anti Dandruffketoconazole | Ketoconazole 1 g/100mL | ShampooTopical | Guangzhou ChuanMa International Trading Co.,Ltd. | 85593-033 |
| Anti- Fungal Miconazole Nitratemiconazole nitrate | Miconazole nitrate 1.42 g/71g | PowderTopical | Premier Brands of America Inc. | 56104-253 |
| Anti-Bacterial HAND SANITIZERethyl alcohol | Alcohol 63 mL/100mL | GelTopical | DISNEY DESTINATIONS,LLC | 72707-029 |
| Anti-Bacterial Wipesbenzalkonium chloride | Benzalkonium chloride .155 g/100g | SolutionTopical | Tongling Jieya Biological Technology Co., Ltd. | 50552-002 |
| Anti-Fungalmiconazole nitrate | Miconazole nitrate .02 g/g | CreamTopical | Universal Distribution Center LLC | 52000-021 |
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