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 |
|---|---|---|---|---|---|---|
| seebeellar clotrimazole 1% antifungal cream | SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 4d80e551-76c2-150a-e063-6394a90a7996 | 2026-03-20 | Warnings | M005 |
| Nail Fungal Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5b5c22-4781-6391-e063-6294a90a7010 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MADRID MUSE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5cecf6-c232-6cd9-e063-6394a90a03e9 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER VALENCIA VIBES | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5de4d6-4c58-f393-e063-6294a90a323a | 2026-03-19 | Warnings | M005 |
| Toenail Fungus Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5e256f-7fd5-f903-e063-6394a90a1160 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MALLORCA BREEZE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5e50de-62fd-f9e9-e063-6394a90af0bd | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MAR BELLA | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d6005d9-5d4d-033e-e063-6294a90ad36f | 2026-03-19 | Warnings | M005 |
| Triple Antifungal | MICONAZOLE NITRATE | Advantice Health, LLC | 9a47fb1b-a41f-4c8a-8e43-7332853c308e | 2026-03-19 | Warnings | M005 |
| Antifungal | CLOTRIMAZOLE | Dynarex Corporation | 4d4cc4b4-c0b4-9e25-e063-6294a90a70b8 | 2026-03-18 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Dynarex Corporation | 4d384385-f3c5-09ba-e063-6394a90aec7f | 2026-03-17 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | e21ccb83-54ff-4605-80bf-7b4b789c7cb7 | 2026-03-17 | Warnings | M005 |
| Peunitory Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 4d2e86bc-5122-ba4a-e063-6394a90acf13 | 2026-03-16 | Warnings | M005 |
| DRMITSUI FOOT ANTIFUNGAL TREATMENT | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 4ce59d31-56fe-d74f-e063-6294a90a7cce | 2026-03-14 | Warnings | M005 |
| NERANTE FUNGUS NAIL PEN | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3984b-53cd-a665-e063-6394a90afe5f | 2026-03-13 | Warnings | M005 |
| FUNGAL NAIL TREATMENT | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3f0e2-b532-b89f-e063-6294a90a7e25 | 2026-03-13 | Warnings | M005 |
| BYT BANGYTONG HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shenzhen Jindali Technology Co., Ltd | 49ed1cc8-e8e5-399c-e063-6394a90a044a | 2026-03-10 | Warnings | M005 |
| Natouch Antifungal Wipes Plus | ANTIFUNGAL ANTISEPTIC WIPES PLUS | Natouch LLC | a85cb307-b3ad-1584-e053-2995a90a9a70 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb6fdfd-116e-14e9-e063-6294a90a4de3 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b | 2026-03-10 | Warnings | M005 |
| SootheSense Toenail Fungus Treatment | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ca2bbeb-3b8a-9482-e063-6294a90a5789 | 2026-03-09 | 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 |