Over-the-counter drug · OTC MONOGRAPH DRUG
Antifungal Pen (Undecylenic acid 25%) NDC 85210-001
Undecylenic acid 25 g/100mL · Liquid · Topical · XF Agencija Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)85210-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85210-0001Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85210-001-01 | 8521000010185210000101 | 1 APPLICATOR in 1 CARTON (85210-001-01) / 3 mL in 1 APPLICATORMarketed from Jan 28, 2025 | |
| 85210-001-02 | 8521000010285210000102 | 3 APPLICATOR in 1 CARTON (85210-001-02) / 3 mL in 1 APPLICATORMarketed from Jan 28, 2025 | |
| 85210-001-03 | 8521000010385210000103 | 6 APPLICATOR in 1 CARTON (85210-001-03) / 3 mL in 1 APPLICATORMarketed from Jan 28, 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)
- Antifungal Pen
- Generic name (nonproprietary)
- undecylenic acid 25%
- Active ingredients
- Undecylenic acid — 25 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- XF Agencija LimitedNDC labeler code 85210
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 85210-001_9e2dd8ab-e1b8-43fd-b156-f3788c591db4SPL ID 9e2dd8ab-e1b8-43fd-b156-f3788c591db4SPL set ID a15d4512-0fc6-424f-9dd3-ab433d9b7a26RxCUI 998329UNII K3D86KJ24NUPC 0850061594884, 0850061594891, 0850061594877
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
N485210000101followed by a unit qualifier and the quantityPackage 85210-0001-01. 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)
Uses For the treatment of athlete's foot, jock itch, and ringworm.
Excerpt only. Read the full label for complete information.
About NDC 85210-001
- What is NDC 85210-001?
- 85210-001 is the product NDC for Antifungal Pen (undecylenic acid 25%), Undecylenic acid 25 g/100mL liquid, listed with the FDA by XF Agencija Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antifungal Pen (Undecylenic acid 25%).
- What is the active ingredient?
- Undecylenic acid.
- Who is the labeler?
- XF Agencija Limited, NDC labeler code 85210. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antifungal Pen?
- 3 other product NDCs are listed under this name. See all Antifungal Pen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antifungal Pen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| antifungal pen | Tolnaftate 1 g/100U | LiquidTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-022 | 84558-0022-0184558-0022-0284558-0022-03 |
| Antifungal Penundecylenic acid | Undecylenic acid 25 g/100mL | LiquidTopical | Guangzhou Mizi Biotechnology Co., Ltd. | 84896-008 | 84896-0008-01 |
| Antifungal Penundecylenic acid, terbinafine hydrochloride | Terbinafine hydrochloride 1 g/100mL; Undecylenic acid 25 g/100mL | LiquidTopical | Hanyang Qisheng (Shenzhen) Technology Co., Ltd. | 87571-001 | 87571-0001-0187571-0001-02 |
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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