Over-the-counter drug · OTC MONOGRAPH DRUG
RoyceDerm ANTIFUNGAL .soap. (Clotrimazole 1%) NDC 85424-019
Clotrimazole 2.26 g/226g · Soap · Topical · RoyceDerm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85424-019-01 | 85424001901 | 226 g in 1 CARTON (85424-019-01)Marketed from Mar 26, 2026 |
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)
- RoyceDerm ANTIFUNGAL .soap.
- Generic name (nonproprietary)
- clotrimazole 1%
- Active ingredients
- Clotrimazole — 2.26 g/226g
- Dosage form
- Soap
- Route
- Topical
- Labeler
- RoyceDerm LLCNDC labeler code 85424
- 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 85424-019_4c43e62b-9061-8962-e063-6394a90aff63SPL ID 4c43e62b-9061-8962-e063-6394a90aff63SPL set ID 4c43e62b-9060-8962-e063-6394a90aff63RxCUI 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
N485424001901followed by a unit qualifier and the quantityPackage 85424-0019-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Wash affected area well and let product sit 2-3 minutes before rinsing Make sure to dry affected area thoroughly. Supervise children in the use of this product. For Athlete's foot: pay special attention to the spaces between the toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily. Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.
Excerpt only. Read the full label for complete information.
About NDC 85424-019
- What is NDC 85424-019?
- 85424-019 is the product NDC for RoyceDerm ANTIFUNGAL .soap. (clotrimazole 1%), Clotrimazole 2.26 g/226g soap, listed with the FDA by RoyceDerm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- RoyceDerm ANTIFUNGAL .soap. (Clotrimazole 1%).
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- RoyceDerm LLC, NDC labeler code 85424. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for RoyceDerm ANTIFUNGAL .soap.?
- 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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