Over-the-counter drug · OTC MONOGRAPH DRUG
Derman Antifungal (Zinc undecylenate) NDC 54312-125
Undecylenic acid 5 g/100g; Zinc undecylenate 18 g/100g · Cream · Topical · Compania Internacional de Comercio, S.A.P.I de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54312-125-01 | 5431201250154312012501 | 1 TUBE in 1 CARTON (54312-125-01) / 25 g in 1 TUBEMarketed from Aug 12, 2013 | |
| 54312-125-02 | 5431201250254312012502 | 1 TUBE in 1 CARTON (54312-125-02) / 50 g in 1 TUBEMarketed from Aug 12, 2013 |
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)
- Derman Antifungal
- Generic name (nonproprietary)
- zinc undecylenate
- Active ingredients
- Undecylenic acid — 5 g/100gZinc undecylenate — 18 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Compania Internacional de Comercio, S.A.P.I de C.V.NDC labeler code 54312
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 54312-125_43fa85f0-78bd-9e8d-e063-6294a90ab9daSPL ID 43fa85f0-78bd-9e8d-e063-6294a90ab9daSPL set ID 0129d801-90f6-49fd-857f-27d6ba9fc66cRxCUI 1435154, 1435159UNII K3D86KJ24N, 388VZ25DURUPC 0354312225027, 0354312225010
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
N454312012501followed by a unit qualifier and the quantityPackage 54312-0125-01. 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)
Uses For the treatment of athlete´s foot.
Excerpt only. Read the full label for complete information.
About NDC 54312-125
- What is NDC 54312-125?
- 54312-125 is the product NDC for Derman Antifungal (zinc undecylenate), Undecylenic acid 5 g/100g; Zinc undecylenate 18 g/100g cream, listed with the FDA by Compania Internacional de Comercio, S.A.P.I de C.V.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Derman Antifungal (Zinc undecylenate).
- What is the active ingredient?
- Undecylenic acid, Zinc undecylenate.
- Who is the labeler?
- Compania Internacional de Comercio, S.A.P.I de C.V., NDC labeler code 54312. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Derman Antifungal?
- 1 other product NDC are listed under this name. See all Derman Antifungal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Derman Antifungal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Derman Antifungaltolnaftate | Tolnaftate 10 mg/g | Aerosol, PowderTopical | Compania Internacional de Comercio, S.A.P.I. de C.V. | 54312-230 | 54312-0230-01 |
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 |
|---|---|---|---|---|
| Lavender Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-015 |
| Sefudun Fungal Nail Patchesglycerin | Glycerin .01 g/1 | PatchTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-006 |
| Hongo Killertolnaftate | Miconazole nitrate .2 g/10g | Aerosol, SprayTopical | Efficient Laboratories Inc | 58593-625 |
| Lights Isopropyl Alcohol Prep Padsisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | SolutionTopical | Lights Medical Manufacture Co., Ltd. | 61333-206 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1000 |
| Tolnaftatemeijer athletes foot liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0591 |
| Mint Blast Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-013 |
| NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-202 |
| Benzo Dermabenzoic acid, salicylic acid, sulfur | Salicylic acid 2.5 g/100g + 2 more ingredients | CreamTopical | LABORATORIOS H.G. C.A. | 84058-130 |
| SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrate | Miconazole nitrate 20 mg/g | CreamTopical | Strategic Sourcing Services LLC | 49348-689 |
| Hongo Killertolnaftate | Tolnaftate 1 g/100g | PowderTopical | Efficient Laboratories Inc | 58593-288 |
| Mycozyl ALtolnaftate | Tolnaftate .3 g/30mL | LiquidTopical | PureTek Corporation | 59088-443 |
| Tolnaftate Cream 1%tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Pharmacy Value Alliance, LLC. | 68016-152 |
| Citrus Detox Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-014 |
| Antifungal Ringworm Treatmentmiconazole nitrate | Miconazole nitrate 2 g/100mL | SprayTopical | Rida LLC | 83004-030 |
| Jock-Ezeclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Bentlin Products LLC | 47832-071 |
| Maximum Strength Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Walgreens Company | 0363-2026 |
| QualiLife persimmon foot and shoeundecylenic acid | Undecylenic acid 10 g/100mL | SprayTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-618 |
| Terramed Just Think Comfort Armor Antifungal Body Wash Tea Treetolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-032 |
| Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatment | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-204 |
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