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 |
|---|---|---|---|---|---|---|
| SUNMARK MICONAZOLE NITRATE antifungal | MICONAZOLE NITRATE | Strategic Sourcing Services LLC | 7c15d95a-5b89-4789-8c91-3f61d7ec7707 | 2025-07-30 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Advanced Rx LLC | e13eb653-3916-444a-ae86-1738c0308b79 | 2025-07-28 | Warnings | M005 |
| Meridian Unwrapped Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Yangzhou Hongshengding Chemical Co.,Ltd. | a2b9570f-312c-4f46-994d-efe057b247aa | 2025-07-28 | Warnings | M005 |
| Meridian Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Yangzhou Hongshengding Chemical Co.,Ltd. | b41b130f-48fd-47d4-a94e-74433ae44de2 | 2025-07-28 | Warnings | M005 |
| Rugby Clotrimazole Antifungal Cream | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | bd567e91-7152-4612-83e0-8e8a00c2d2c5 | 2025-07-25 | Warnings | M005 |
| Hongocura | UNDECYLENIC ACID, ZINC UNDECYLENATE | MENPER DISTRIBUTORS, INC. | c69b735e-0ffe-4328-bd9f-3c1ac6798c08 | 2025-07-22 | Warnings | M005 |
| Hongocura Pinceladas | UNDECYLENIC ACID | Menper Distributors, Inc. | 4b9a3a70-d646-47c6-b969-5c4d759d23a4 | 2025-07-22 | Warnings | M005 |
| Hongocura M | UNDECYLENIC ACID | MENPER DISTRIBUTORS, INC. | b4adb7b0-59b4-4b3c-9b0e-1869bb543174 | 2025-07-22 | Warnings | M005 |
| Hongocura S | UNDECYLENIC ACID | MENPER DISTRIBUTORS, INC. | 4a21f371-bfc1-4e66-af16-55b3283872b7 | 2025-07-22 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Cream 1oz | MICONAZOLE NITRATE | Front Pharmaceutical PLC | 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 2025-07-18 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Cream 4oz | MICONAZOLE NITRATE | Front Pharmaceutical PLC | 3a382b79-dde9-dde0-e063-6294a90a53bb | 2025-07-18 | Warnings | M005 |
| FifthPulse clotrimazole cream 4oz | CLOTRIMAZOLE 1% | Front Pharmaceutical PLC | 3a389093-48f2-29cb-e063-6294a90ada37 | 2025-07-18 | Warnings | M005 |
| PHARMBANNER Tea Tree Oil Antifungal Soap. | TEA TREE OIL ANTIFUNGAL SOAP. | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a0860b0-346e-7024-e063-6394a90ace81 | 2025-07-16 | Warnings | M005 |
| TopCare Antifungal | CLOTRIMAZOLE | Topco Associates LLC | 6757eb2a-73e0-4bd0-a332-5713fdf3445d | 2025-07-16 | Warnings | M005 |
| UpandUp Clotrimazole | CLOTRIMAZOLE | Target Corporation | cb2b7d38-9988-493b-9843-56c2f59eed2f | 2025-07-16 | Warnings | M005 |
| Jock Itch | CLOTRIMAZOLE | TARGET Corporation | 1ae551e7-69de-4eef-b4f7-5e1a880e631d | 2025-07-16 | Warnings | M005 |
| Athletes Foot | CLOTRIMAZOLE | FRED'S, INC. | d2d8f44e-2dfa-446b-855e-86e0d6d2d0df | 2025-07-15 | Warnings | M005 |
| Tolnaftate Antifungal | TOLNAFTATE | STRATEGIC SOURCING SERVICES LLC | 97ffb6fd-5670-4783-b805-88fe9e43ca96 | 2025-07-15 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | STRATEGIC SOURCING SERVICES LLC | 966a1000-3b08-4f2c-a9f8-568f2524b717 | 2025-07-15 | Warnings | M005 |
| Tolnaftate Antifungal | TOLNAFTATE | Amerisource Bergen | a3c9b783-4a36-46b3-a0dc-0696907eaebb | 2025-07-15 | 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 |