Over-the-counter drug · OTC MONOGRAPH DRUG
CLARUS Antifungal (Tolnaftate) NDC 44577-002
Tolnaftate 1 g/100mL · Solution · Topical · Clinical Therapeutic Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44577-002-01 | 4457700020144577000201 | 15 mL in 1 BOTTLE (44577-002-01)Marketed from Feb 6, 2017 |
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)
- CLARUS Antifungal
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — 1 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Clinical Therapeutic SolutionsNDC labeler code 44577
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 44577-002_09740b13-55d0-2604-e063-6294a90a158cSPL ID 09740b13-55d0-2604-e063-6294a90a158cSPL set ID 308a91d1-3511-4e2d-a62f-a31d77d70e06RxCUI 313423, 1299066UNII 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
N444577000201followed by a unit qualifier and the quantityPackage 44577-0002-01. 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 effective treatment of most athlete's foot and ringworm. Relieves: Prevents the reoccurrence of most athlete's foot with daily use. Itching Scaling Cracking Redness Soreness Burning Irritation
Excerpt only. Read the full label for complete information.
About NDC 44577-002
- What is NDC 44577-002?
- 44577-002 is the product NDC for CLARUS Antifungal (tolnaftate), Tolnaftate 1 g/100mL solution, listed with the FDA by Clinical Therapeutic Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CLARUS Antifungal (Tolnaftate).
- What is the active ingredient?
- Tolnaftate.
- Who is the labeler?
- Clinical Therapeutic Solutions, NDC labeler code 44577. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CLARUS Antifungal?
- 2 other product NDCs are listed under this name. See all CLARUS Antifungal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CLARUS 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) |
|---|---|---|---|---|---|
| CLARUS Antifungaltolnaftate | Tolnaftate 10 mg/g | CreamTopical | Clinical Therapeutic Solutions | 44577-470 | 44577-0470-00 |
| CLARUS Antifungaltolnaftate | Tolnaftate 1 g/100g | CreamTopical | Clinical Therapeutic Solutions | 44577-001 | 44577-0001-01 |
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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