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 |
|---|---|---|---|---|---|---|
| SSPROTIP X Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52512e7e-5e28-4383-e063-6294a90a448a | 2026-05-21 | Warnings | M005 |
| Vrenmol Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52516861-e386-d0cb-e063-6394a90a17d0 | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Toenail Renewal Solution | TOLNAFTATE,UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52519110-a3c9-21da-e063-6294a90abbce | 2026-05-21 | Warnings | M005 |
| NERANTE Antifungal Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangzhou Xinhongda Trading Service Co., Ltd. | 52281e10-59db-1d1c-e063-6394a90aadfe | 2026-05-21 | Warnings | M005 |
| Fungal Nail Repair Pen | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 523c32f7-b803-bf79-e063-6394a90aad5a | 2026-05-20 | Warnings | M005 |
| Medi-First Clotrimazole 1% ANTIFUNGAL Cream | CLOTRIMAZOLE | Unifirst First Aid Corporation | 522eeb91-8378-32f4-e063-6394a90aff43 | 2026-05-20 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 47cf1251-5965-045a-e063-6394a90ab04f | 2026-05-19 | Warnings | M005 |
| APUREE PRO Nailtific Maximum Strength Antifungal Patches | APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES | Guangzhou Meixi Biotechnology Co., Ltd. | 5218bd5d-53b4-107f-e063-6394a90ae769 | 2026-05-18 | M005 | |
| APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen | APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN | Guangzhou Meixi Biotechnology Co., Ltd. | 521a0e40-a218-fabb-e063-6294a90ae9a2 | 2026-05-18 | Warnings | M005 |
| Beukow Antifungal Pen | UNDECYLENIC ACID 25% ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 511d1edf-dfda-477c-e063-6294a90aa423 | 2026-05-17 | Warnings | M005 |
| Nail Repair Pen | NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 520f6514-6660-d6a8-e063-6394a90adf82 | 2026-05-17 | Warnings | M005 |
| Fungicure Intensive | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 1f1b413f-278e-434f-8590-4cf731663f5c | 2026-05-15 | Warnings | M005 |
| Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal | TOLNAFTATE | Scholl's Wellness Company LLC | 8abd6d8e-c69e-4374-ace8-d42b2d3e171e | 2026-05-14 | Warnings | M005 |
| Dr.Scholl s Odor X Athlete s Foot | TOLNAFTATE | Scholl's Wellness Company LLC | 0e864882-5e00-491e-a008-0762c131637a | 2026-05-14 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Rugby Laboratories | 50c46cf5-3e64-9e0f-e063-6294a90a2317 | 2026-05-14 | Warnings | M005 |
| TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes | TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 3d53463d-8d8e-9030-e063-6294a90ab454 | 2026-05-13 | Warnings | M005 |
| Anti-Fungal Powder | MICONAZOLE NITRATE | CVS Pharmacy | 1651bdd7-ab15-7a2d-e063-6294a90a8b91 | 2026-05-11 | Warnings | M005 |
| Lightning X Hand Cleanser | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 51861f1e-8961-e876-e063-6394a90a2fd0 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Antifungal Patches PRO | APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO | Guangzhou Meixi Biotechnology Co., Ltd | 5189ebc5-8ee5-1b2c-e063-6294a90af5c8 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro | APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO | Guangzhou Meixi Biotechnology Co., Ltd. | 518abf2b-6ac8-ab9b-e063-6294a90ae693 | 2026-05-11 | 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 |