Tolfyra
- Product NDC
- 85477-331
- 11-digit product format
- 854770331
- Labeler code
- 85477
- Product ID
- 85477-331_9a2daff0-df69-4dd4-9b2b-84d1b74de374
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Oncora Pharma, LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-01
- Substance
- TOLNAFTATE
- Active strength
- .3 g/30mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolfyra
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | .3 g/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06KB629TKV | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 313423 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b28ee9f2-fc45-4336-b374-be7aa51d44e9 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85477-331-01 | Tolfyra | 30 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 30 | 6 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clotrimazole | DRS. CLOTRIMAZOLE | OL PHARMA TECH,LLC | b0e9fc77-6d5c-2472-e053-2995a90a3de4 | 2025-01-09 | Warnings | M005 |
| Anti-Bacterial Wipes | BENZALKONIUM CHLORIDE | Tongling Jieya Biological Technology Co., Ltd. | d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d | 2025-01-04 | Warnings | M005 |
| AVON HeXashield Athletes Foot Cream | TOLNAFTATE | Tai Guk Pharm. Co., Ltd. | 8f2b6a09-8cb0-0d17-e053-2995a90aa07f | 2025-01-01 | Warnings | M005 |
| Tolnaftate | TOLNAFTATE 1% | Trifecta Pharmaceuticals USA, LLC | 091b907f-544a-86c9-e063-6294a90a5d87 | 2024-12-31 | Warnings | M005 |
| terrasil Fungal Treatment | CLOTRIMAZOLE | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 278290f9-be14-81a8-e063-6294a90ad8cc | 2024-12-26 | Warnings | M005 |
| DEO PEDICO ABOVE NEYMAR JR MEN | DEO PEDICO ABOVE NEYMAR JR MEN | BASTON INDUSTRIA DE AEROSSOIS LTDA | ed4a9844-f20b-da5d-e053-2995a90adc09 | 2024-12-26 | Warnings | M005 |
| Vite20 | MICONAZOLE NITRATE | Blaine Labs Inc. | 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71 | 2024-12-24 | Warnings | M005 |
| Vite20 | UNDECYLENIC ACID | Blaine Labs Inc. | 18f8ea1c-360e-43c0-98df-5816af4dec66 | 2024-12-24 | Warnings | M005 |
| Tolnaftate Cream 1% ANTIFUNGAL | FAMILY WELLNESS TOLNAFTATE | Trifecta Pharmaceuticals USA, LLC | 915759af-0d7f-6a87-e053-2a95a90acbd6 | 2024-12-20 | Warnings | M005 |
| Rugby Clotrimazole Antifungal Cream | CLOTRIMAZOLE | Rugby Laboratories | a1365bc7-b376-adca-e053-2a95a90acf19 | 2024-12-20 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL MICONAZOLE POWDER SPRAY | Premier Brands of America Inc. | dc7a23bb-b246-89b1-e053-2995a90a9f2d | 2024-12-20 | Warnings | M005 |
| Warrior Antifungal Foot | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | cf2e9dc1-275b-4454-e053-2995a90af295 | 2024-12-20 | Warnings | M005 |
| Tolnaftate Cream 1% | TOLNAFTATE | Pharmacy Value Alliance, LLC. | 3abfd734-229b-1a0e-e054-00144ff88e88 | 2024-12-20 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Derma Care Research Labs, LLC | fbc1a55e-b994-4962-e053-6394a90a13ba | 2024-12-19 | Warnings | M005 |
| Novonail Solution | TOLNAFTATE 1% | Derma Care Research Labs, LLC | 013d6107-e3b0-0264-e063-6394a90ae1e2 | 2024-12-19 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Rugby | f420de00-408f-9a2c-e053-2995a90adced | 2024-12-17 | Warnings | M005 |
| Relispray Antifungal Liquid | TOLNAFTATE | Midas-Care Pharmaceuticals Pvt. Ltd. | 6522ad59-f810-408c-a9f9-9359d79302ce | 2024-12-17 | Warnings | M005 |
| Clotrimazole | FAMILY WELLNESS CLOTRIMAZOLE | Trifecta Pharmaceuticals USA LLC | 915759af-0d7b-6a87-e053-2a95a90acbd6 | 2024-12-13 | Warnings | M005 |
| Blistex Odor-Eaters Powder | TOLNAFTATE | Blistex Inc | 819edb2f-dda7-45c3-b0da-ebcae354154e | 2024-12-12 | Warnings | M005 |
| Walgreens Athletes Foot | TOLNAFTATE SPRAY | Walgreens | c68ad65d-b016-0069-e053-2995a90ae7ef | 2024-12-11 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313423 | tolnaftate 1 % Topical Solution | PSN | b28ee9f2-fc45-4336-b374-be7aa51d44e9 | 6 |
| 313423 | tolnaftate 10 MG/ML Topical Solution | SCD | b28ee9f2-fc45-4336-b374-be7aa51d44e9 | 6 |
| 313423 | tolnaftate 1 % Topical Solution | SY | b28ee9f2-fc45-4336-b374-be7aa51d44e9 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85477-331-01 | 85477033101 | 30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) | 30 ml | 2026-05-01 | No | No | Current |