Over-the-counter drug · OTC MONOGRAPH DRUG
Tolfyra (Tolnaftate) NDC 85477-331
Tolnaftate .3 g/30mL · Liquid · Topical · Oncora Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85477-331-01 | 8547703310185477033101 | 30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01)Marketed from May 1, 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)
- Tolfyra
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — .3 g/30mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Oncora Pharma, LLCNDC labeler code 85477
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 85477-331_9a2daff0-df69-4dd4-9b2b-84d1b74de374SPL ID 9a2daff0-df69-4dd4-9b2b-84d1b74de374SPL set ID b28ee9f2-fc45-4336-b374-be7aa51d44e9RxCUI 313423UNII 06KB629TKV
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
N485477033101followed by a unit qualifier and the quantityPackage 85477-0331-01. 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 most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
Excerpt only. Read the full label for complete information.
About NDC 85477-331
- What is NDC 85477-331?
- 85477-331 is the product NDC for Tolfyra (tolnaftate), Tolnaftate .3 g/30mL liquid, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tolfyra (Tolnaftate).
- What is the active ingredient?
- Tolnaftate.
- Who is the labeler?
- Oncora Pharma, LLC, NDC labeler code 85477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tolfyra?
- 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 |
|---|---|---|---|---|
| CVS Health Athletes Foottolnaftate | Tolnaftate 10 mg/g | CreamTopical | CVS Pharmacy, Inc. | 69842-336 |
| TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-221 |
| Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-108 |
| Dr CANUSO fungal nail erasertolnaftate oil | Tolnaftate .3 g/28g | OilTopical | Renu Laboratories, LLC | 76348-410 |
| cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus pen | Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-220 |
| Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-106 |
| Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-107 |
| Hongo Killertolnaftate | Tolnaftate .1 g/10g | Aerosol, PowderTopical | Efficient Laboratories Inc | 58593-285 |
| Pedikleertolnaftate | Tolnaftate 1 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-354 |
| Athletes Footmiconazole nitrate | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Premier Brands of America Inc | 56104-912 |
| Tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Sheffield Pharmaceuticals LLC | 11527-051 |
| THERA Antifungal Bodymiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | McKesson Medical-Surgical Inc. | 68599-0207 |
| LMNOOP MENS Private Health Creammens private health cream | Oatmeal 1 g/100g | CreamTopical | Shenzhen Ishan Technology Co., Ltd | 73076-210 |
| Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Beautivity LLC | 85398-036 |
| Antifungal Bodymiconazole nitrate | Miconazole nitrate 2 mg/100mL | CreamTopical | McKesson | 68599-0206 |
| LYSSERA Fungal Nail Renewalundecylenic acid 25% antifunga | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-174 |
| Anti-Fungal Powdermiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | The Kroger Co. | 30142-947 |
| Hydrocortisone 1%hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Chain Drug Marketing Association Inc. | 83324-329 |
| Antifungal Medicated Body Washtolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-012 |
| Vamy ANTIFUNGALtolnaftate 1% antifungal | Tolnaftate 1 g/100mL | SprayTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-176 |
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