Opti-Nail 2-in-1
- Product NDC
- 55505-219
- 11-digit product format
- 555050219
- Labeler code
- 55505
- Product ID
- 55505-219_22f25809-6afc-43fc-81dc-de6745e20ab8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Kramer Laboratories
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-20
- Marketing end
- 2027-01-01
- Substance
- TOLNAFTATE
- Active strength
- 1 g/100mL
- NDC exclude flag
- No
- 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
- Opti-Nail 2-in-1
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06KB629TKV | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 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 |
|---|---|---|---|---|---|---|
| 55505-219-67 | Opti-Nail 2-in-1 | 5 mL in 1 TUBE, WITH APPLICATOR | LIQUID | 5 | 4 |
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 NAILS REPAIRING ESSENCE | PEPPERMINT OIL | Zhenping Renren Industry Co., Ltd. | 3e82649c-d784-d64c-e063-6294a90ac95d | 2025-09-11 | Warnings | M005 |
| equate Athletes Foot | TOLNAFTATE | Wal-Mart Stores Inc | e90297d0-0f87-4ae3-b9b7-959266d57c24 | 2025-09-11 | Warnings | M005 |
| Bee Venom Toenail Fungus Treatment | BEE VENOM TOENAIL FUNGUS TREATMENT | Shenzhen Earth Surface Trading Co., Ltd. | 3e7d22b0-2f57-fcac-e063-6394a90aefd9 | 2025-09-10 | Warnings | M005 |
| Amerfresh Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | cdc4f0ff-07bd-47c8-850b-1698308bb660 | 2025-09-09 | Warnings | M005 |
| Antifungal Cream | MICONAZOLE NITRATE | Encube Ethicals, Inc. | 8be4bbfa-424c-4ccf-b8bc-65b16c126053 | 2025-09-04 | Warnings | M005 |
| ANTIFUNGAL | CLOTRIMAZOLE | Encube Ethicals, Inc. | afbc28f8-bb76-424d-9d73-136e6c283ead | 2025-09-04 | Warnings | M005 |
| Hermon Balanitis relief kit | SULFUR 1X HPUS | Beautivity LLC | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 2025-09-02 | Warnings | M005 |
| Extra Strength Nail Fungus Treatment | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3abc0892-e52b-a40f-e063-6294a90a0e35 | 2025-09-02 | Warnings | M005 |
| Hermon Balanitis Cream | SULFUR 1X HPUS | Beautivity LLC | 3dba4e4b-8224-6a96-e063-6394a90a9129 | 2025-09-01 | Warnings | M005 |
| Caseys | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | a29d6c19-01aa-45b0-92cd-3f1148bad4f8 | 2025-08-30 | Warnings | M005 |
| Tolnafate | TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE | VALU MERCHANDISERS, CO. | 1d258684-9034-460c-953d-78e2b5198167 | 2025-08-26 | Warnings | M005 |
| Femmesil Maximum Strength | MICONAZOLE NITRATE | Aidance Skincare & Topical Solutions, LLC | d8b01fe1-4465-497b-909e-f51f31fdf833 | 2025-08-25 | Warnings | M005 |
| femmesil Ultra Therapy | CLOTRIMAZOLE | Aidance Scientific, Inc. | 3d36794a-07d0-860c-e063-6294a90a6e8f | 2025-08-25 | Warnings | M005 |
| Nedtol Folliculitis Treatment Creams | MICONAZOLE NITRATE | Jiashen International Trade Limited | 3d0a1e39-82e4-9337-e063-6294a90aa9a3 | 2025-08-23 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | 6b74d405-42d6-4c46-ba78-3007d1e8ffb8 | 2025-08-23 | Warnings | M005 |
| FUNGLARA Anti Fungal | UNDECYLENIC ACID | FUNGLARA LLC | a23c2399-36ea-4f22-8140-066e22c9a862 | 2025-08-20 | Warnings | M005 |
| Rapid MicroGel | TOLNAFTATE | The Tetra Corporation | afb6d7c4-1f75-4694-83c8-d6469250d6a1 | 2025-08-19 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | AvPAK | 3ca3b475-7b69-442a-e063-6294a90a7b3f | 2025-08-18 | Warnings | M005 |
| Formula 3 | TOLNAFTATE | The Tetra Corporation | 0895274b-a09d-4264-a43f-852e44eb3163 | 2025-08-18 | Warnings | M005 |
| Formula 7 - The Solution | TOLNAFTATE | The Tetra Corporation | 18619649-7f79-4b6e-8b7c-69d70365d557 | 2025-08-18 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2627287 | Opti-Nail 1 % Topical Solution | PSN | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
| 313423 | tolnaftate 1 % Topical Solution | PSN | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
| 2627287 | tolnaftate 10 MG/ML Topical Solution [Opti-Nail] | SBD | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
| 313423 | tolnaftate 10 MG/ML Topical Solution | SCD | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
| 2627287 | Opti-Nail 10 MG/ML Topical Solution | SY | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
| 313423 | tolnaftate 1 % Topical Solution | SY | bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55505-219-67 | 55505021967 | 5 mL in 1 TUBE, WITH APPLICATOR (55505-219-67) | 5 ml | 2023-01-20 | 2027-01-01 | No | No | Historical |