Over-the-counter drug · OTC MONOGRAPH DRUG
Thera plus Antifungal Tolnaftate (tolnaftate) NDC 80684-040
Tolnaftate 10 mg/g · Cream · Topical · FOURSTAR GROUP USA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80684-040-01 | 80684004001 | 1 TUBE in 1 BOX (80684-040-01) / 14 g in 1 TUBEMarketed from Jan 30, 2022 |
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)
- Thera plus Antifungal Tolnaftate
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- FOURSTAR GROUP USA, INC.
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 80684-040_08a0d819-d9c5-15e9-e063-6294a90acb44SPL ID 08a0d819-d9c5-15e9-e063-6294a90acb44SPL set ID c628dda8-7a6d-5f3a-e053-2995a90a35f8RxCUI 103951UNII 06KB629TKVUPC 0049696866637
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
N480684004001followed by a unit qualifier and the quantityPackage 80684-0040-01. 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 proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching , burning , and cracking
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Molecular AFtolnaftate | Tolnaftate .01 mg/mL | OilTopical | Renu Laboratories, LLC | 76348-401 |
| SimplyVital Antifungal Clotrimazoleclotrimazole | Clotrimazole 10 mg/mL | CreamTopical | Alpha Plants Inc | 82460-990 |
| Sovs Fungal Nail Repair Renewalundecylenic acid 25% fungal nail repair renewal | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-232 |
| WISH HAND SANITIZER Lychee Vanilla Milkalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-208 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamTopical | Walgreen Company | 0363-2105 |
| BODYKOO JOCK ITCH Creamclotrimazole1% jock itch cream | Clotrimazole 1 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-228 |
| WISH HAND SANITIZER Strawberry Muskalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-205 |
| HSENJT Antifungal Creammiconazole nitrate | Miconazole nitrate 20 mg/g | CreamTopical | Huizhou Haosen Trading Co., Ltd. | 87951-001 |
| Hongo Killerundecylenic acid | Undecylenic acid 2 mg/10mL | SprayTopical | Efficient Laboratories Inc | 58593-601 |
| SIMPLY VITAL Antifungal Creamclotrimazole | Clotrimazole 10 mg/mL | CreamTopical | ALPHA PLANTS INC | 82460-344 |
| BODYKOO ATHLETE FOOT Creammiconazole nitrate2% athlete foot cream | Miconazole nitrate 2 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-229 |
| WISH HAND SANITIZER Sea Salt Green Herbsalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-206 |
| Nail Renovar Plustolnaftate | Tolnaftate 1 g/100mL | LiquidTopical | SOHM, Inc | 50405-030 |
| Hongo Killertolnaftate | Miconazole nitrate .2 g/10g | Aerosol, SprayTopical | Efficient Laboratories Inc | 58593-625 |
| Miconazole Nitrateathletes foot liquid | Miconazole nitrate 3 g/150g | SprayTopical | Walgreens Company | 0363-4208 |
| Fitcube NAIL REPAIR PENundecylenic acid 25% tolnaftate 1% nail repair pen | Undecylenic acid 25 g/100mL; Tolnaftate 1 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-230 |
| WISH HAND SANITIZER Marshmallow Vanillaalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-207 |
| Recuren Plus Jock Itch Creammiconazole nitrate 2% | Miconazole nitrate 20 mg/g | CreamTopical | REGENEREN PLUS LTD | 87014-004 |
| Lightning X Hand Cleanserethyl alcohol | Alcohol 62 mL/100mL | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-122 |
| Tolnaftatemeijer athletes foot liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0591 |
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