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 |
|---|---|---|---|---|---|---|
| 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 |
| Natouch Antifungal Antiseptic Wipes | ANTIFUNGAL ANTISEPTIC WIPES | Natouch LLC | 4c84c556-8d0b-ec28-e063-6294a90af1d3 | 2026-03-08 | Warnings | M005 |
| ANTIFUNGAL Cream | ANGELICA DAHURICA EXTRACTT, ASIATIC ACID | Guangzhou Mizi Biotechnology Co., LTD. | 4c586cd9-d356-34d8-e063-6294a90a4d11 | 2026-03-06 | Warnings | M005 |
| FungiFoam | TOLNAFTATE | The Tetra Corporation | 2449e8e5-9d7e-4119-9e7a-378efe55f875 | 2026-03-06 | Warnings | M005 |
| RoyceDerm ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4c43e62b-9060-8962-e063-6394a90aff63 | 2026-03-05 | Warnings | M005 |
| Derman Antifungal | TOLNAFTATE | Compania Internacional de Comercio, S.A.P.I. de C.V. | 5784a783-1056-4d50-8d87-2df4f8e16b09 | 2026-03-05 | Warnings | M005 |
| Antifungal Powder | TOLNAFTATE | ARMY & AIR FORCE EXCHANGE SERVICE | 4c39e121-4919-a482-e063-6294a90a98cd | 2026-03-04 | Warnings | M005 |
| ViLLsure Antifungal Pen | UNDECYLENIC ACID 25%ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c28cf04-94ad-8db6-e063-6394a90a2eed | 2026-03-03 | 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 |