Fungi Nail Anti-Fungal Pen
- Product NDC
- 55505-193
- 11-digit product format
- 555050193
- Labeler code
- 55505
- Product ID
- 55505-193_c41f43f6-0f87-4dbb-89f2-6e0a36ac081b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Kramer Laboratories
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-03-01
- Substance
- TOLNAFTATE
- Active strength
- 1 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Fungi Nail Anti-Fungal Pen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | 1 g/100mL |
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 |
|---|---|
| 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55505-193-51 | Fungi Nail Anti-Fungal Pen | 3 mL in 1 TUBE, WITH APPLICATOR | LIQUID | 3 | 6 | |
| 55505-193-51 | Fungi Nail Anti-Fungal Pen | 1 in 1 CARTON | LIQUID | 1 | 6 | |
| 55505-193-60 | Fungi Nail Anti-Fungal Pen | 1 in 1 CARTON | LIQUID | 1 | 6 | |
| 55505-193-60 | Fungi Nail Anti-Fungal Pen | 2 in 1 PACKAGE | LIQUID | 2 | 6 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| FUNGAL NAIL TREATMENT kit .liquid. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c93390-ee07-4f78-e063-6394a90add42 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit .cream. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c9d9fa-09ad-e26a-e063-6394a90a0ed9 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56cb7085-87d8-4273-e063-6394a90ac5df | 2026-07-17 | Warnings | M005 |
| BeamBalm ANTIFUNGAL FOOT CARE | TOLNAFTATE 1% ANTIFUNGAL FOOT CARE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b10492-894c-33e1-e063-6394a90a8c0f | 2026-07-17 | Warnings | M005 |
| Foot Choice-Nail Fungal Pen | UNDECYLENIC ACID | Foot Choice LLC | 4b0036a6-8751-4f44-b6b1-5be57fa92cdc | 2026-07-17 | Warnings | M005 |
| 2% MICONAZOLE NITRATE ANTIFUNGAL Cream | 2% MICONAZOLE NITRATE ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56b54359-db21-b8b4-e063-6394a90a6f8c | 2026-07-16 | Warnings | M005 |
| DRAVYNOR BALANITIS RELIEF Cream | MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b76a52-0743-4fe6-e063-6294a90a98a8 | 2026-07-16 | Warnings | M005 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | 5% BENZOYL PEROXIDE FOLLICULITIS CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56c558fa-303f-fc52-e063-6394a90a72f0 | 2026-07-16 | Warnings | M005 |
| Antifungal Ringworm Treatment Cream | MICONAZOLE NITRATE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 56a2ceea-c4c0-c30c-e063-6394a90a0e6a | 2026-07-15 | Warnings | M005 |
| Medi-First Antifungal Cream Miconazole Cream | MICONAZOLE | Unifirst First Aid Corporation | 56a51b75-9c23-bcd2-e063-6394a90a9b12 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Tinea Treatment | CLEAR ROOT LABS TINEA TREATMENT | Aidance Scientic Inc., DBA Aidance Skincare & Topicals | 56a67bad-c677-d3b7-e063-6394a90ad205 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Antifungal Treatment | CLEAR ROOT LABS ANTIFUNGAL TREATMENT | Aidance Scientific, Inc., DBA Aidance Skincare & Topicals | 5696bf23-230a-5f37-e063-6294a90a7413 | 2026-07-15 | Warnings | M005 |
| BeamBalm ANTIFUNGAL NAIL Liquid | TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID | Jiangxi Yudexi Pharmaceutical Co., LTD | 56b17e50-bff1-5eb0-e063-6294a90a3c08 | 2026-07-15 | Warnings | M005 |
| terrasil Antifungal Cleansing Bar | CLOTRIMAZOLE | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 10a4fde0-87e1-4474-bcb5-255b0a7f1ecb | 2026-07-14 | Warnings | M005 |
| OAKDOLCHE Tea Tree Oil Antifungal | TOLNAFTATE | Nanjing Qiaotun Technology Co., Ltd. | 569dee15-e68d-220e-e063-6294a90af7c5 | 2026-07-14 | Warnings | M005 |
| Kimtara Nail Fungus Treatment | KIMTARA NAIL FUNGUS TREATMENT | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 5678e260-10c4-f203-e063-6294a90a6223 | 2026-07-13 | Warnings | M005 |
| Aiilo NAIL FUNGUS TREATMENT | UNDECYLENIC ACID 25% | Guangzhou Huixue Biotechnology Co., Ltd. | 5689ac31-4d23-0fcc-e063-6394a90ac75b | 2026-07-13 | M005 | |
| MIWIFY ANTIFUNGAL NAIL REPAIR PEN | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56519b25-f3c8-bcac-e063-6394a90af879 | 2026-07-11 | Warnings | M005 |
| Joymeey FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5652a22e-7b43-3c31-e063-6294a90ae4f1 | 2026-07-11 | Warnings | M005 |
| iBeaLee Nail Repair Pen | IBEALEE NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 564dc711-7fe2-7a8d-e063-6294a90aac26 | 2026-07-10 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313423 | tolnaftate 1 % Topical Solution | PSN | 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | 6 |
| 313423 | tolnaftate 10 MG/ML Topical Solution | SCD | 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | 6 |
| 313423 | tolnaftate 1 % Topical Solution | SY | 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55505-193-51 | 55505019351 | 1 TUBE, WITH APPLICATOR in 1 CARTON (55505-193-51) / 3 mL in 1 TUBE, WITH APPLICATOR | 2020-03-01 | 0000-00-00 | No | No | Current | |
| 55505-193-60 | 55505019360 | 2 CARTON in 1 PACKAGE (55505-193-60) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 3 mL in 1 TUBE, WITH APPLICATOR | 2 carton | 2021-05-18 | No | No | Current |