Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength Nail Fungus Treatment (Undecylenic acid, tolnaftate) NDC 85966-001
Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL · Liquid · Topical · GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85966-001-01 | 8596600010185966000101 | 30 mL in 1 BOTTLE (85966-001-01)Marketed from Jul 25, 2025 | |
| 85966-001-02 | 8596600010285966000102 | 2 BOTTLE in 1 BOX (85966-001-02) / 30 mL in 1 BOTTLEMarketed from Jul 25, 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)
- Extra Strength Nail Fungus Treatment
- Generic name (nonproprietary)
- undecylenic acid, tolnaftate
- Active ingredients
- Tolnaftate — 1 g/100mLUndecylenic acid — 25 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTDNDC labeler code 85966
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 85966-001_3dced015-71fd-f6ab-e063-6294a90a0dc3SPL ID 3dced015-71fd-f6ab-e063-6294a90a0dc3SPL set ID 3abc0892-e52b-a40f-e063-6294a90a0e35RxCUI 2691548UNII 06KB629TKV, K3D86KJ24N
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
N485966000101followed by a unit qualifier and the quantityPackage 85966-0001-01. 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)
For the effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and brittleness Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For effective relief of itching, scaling, burning, redness, soreness, and irritation. Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.
Excerpt only. Read the full label for complete information.
About NDC 85966-001
- What is NDC 85966-001?
- 85966-001 is the product NDC for Extra Strength Nail Fungus Treatment, Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL liquid, listed with the FDA by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength Nail Fungus Treatment (Undecylenic acid, Tolnaftate).
- What is the active ingredient?
- Tolnaftate, Undecylenic acid.
- Who is the labeler?
- GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD, NDC labeler code 85966. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Extra Strength Nail Fungus Treatment?
- 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 |
|---|---|---|---|---|
| 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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