FUNGAL NAIL TREATMENT
- Product NDC
- 85308-002
- 11-digit product format
- 853080002
- Labeler code
- 85308
- Product ID
- 85308-002_31dd1fb8-e662-eae8-e063-6394a90ab5e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FUNGAL NAIL TREATMENT
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Gaoye Marketing Inc
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-03
- Substance
- UNDECYLENIC ACID
- Active strength
- 25 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 85308-002 | I | Inactivated by FDA | 2026-09-14 | ||
| excluded package | package | 85308-002 | 85308-002-01 | I | Inactivated by FDA | 2026-09-14 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85308-002-01 | FUNGAL NAIL TREATMENT | 30 mL in 1 BOTTLE | LIQUID | 30 | 1 |
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 |
|---|---|---|---|---|---|---|
| Defense Antifungal Medicated Bar | TOLNAFTATE | Defense Soap LLC | 812d78ea-a14a-e3a2-e053-2a91aa0a6ff5 | 2026-09-09 | Warnings | M005 |
| Medline | MICONAZOLE NITRATE | Medline Industries, LP | 0d997d1d-8663-201f-e063-6394a90a285e | 2026-09-08 | Warnings | M005 |
| Remedy Antifungal With Olivamine | MICONAZOLE NITRATE | Medline Industries, LP | 28c5183e-05b4-1754-e054-00144ff8d46c | 2026-09-08 | Warnings | M005 |
| Claravie | MICONAZOLE NITRATE 2% | Gentell LLC | 5afdc429-cb44-703c-e063-6294a90a971a | 2026-09-08 | Warnings | M005 |
| Inlifay ANTIFUNGAL | MICONAZOLE NITRATE 2% ANTIFUNGAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a832f39-ac11-d8b3-e063-6394a90acb39 | 2026-09-06 | Warnings | M005 |
| Noicaky FUNGAL NAIL Patches | TOLNAFTATE 1% FUNGAL NAIL PATCHES | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5adcc5f7-2d47-2ad7-e063-6294a90a4848 | 2026-09-06 | Warnings | M005 |
| LIFE66II ANTIFUNGAL NAIL | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5ab83796-0780-3b58-e063-6394a90a2e4e | 2026-09-05 | Warnings | M005 |
| FGPER Topical Antifungal Pen | UNDECYLENIC ACID | Guangzhou ChuanMa International Trading Co.,Ltd. | 5abdcbff-6ab1-2f0a-e063-6294a90a57ef | 2026-09-05 | Warnings | M005 |
| Jock Itch Powder | MICONAZOLE NITRATE | Premier Brands of America Inc | 5aaacc88-6752-ab47-e063-6394a90af7cd | 2026-09-04 | Warnings | M005 |
| ANTIFUNGAL BODY WASH | TOLNAFTATE | Guangzhou ChuanMa International Trading Co.,Ltd. | 5a695043-f776-df5a-e063-6394a90ac274 | 2026-09-01 | Warnings | M005 |
| KetoconClear Cream | KETOCONAZOLE | Guangzhou Shunfei Network Technology Co., Ltd. | 5a54eebe-5b4a-28dd-e063-6294a90a607f | 2026-08-31 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | InvaDerm Corporation | 5a5cfed9-0587-7bef-e063-6294a90a64bf | 2026-08-31 | Warnings | M005 |
| Gembooxt RINGWORM Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangdong Quadrant Ecological Technology Co., Ltd. | 464a33c3-6d16-0cfd-e063-6294a90abf4b | 2026-08-27 | Warnings | M005 |
| DrAny NAIL FUNGUS TREATMENT | UNDECYLENIC ACID, TOLNAFTATE | Hong Kong Juxin Negosyo Kag Komersyo Co., Limited | 59ef412b-fc7b-0a84-e063-6394a90abf25 | 2026-08-26 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 7fd4037e-d350-47b7-a7d9-a43b8e366fa0 | 2026-08-25 | Warnings | M005 |
| WISH HAND SANITIZER pink dragon blossom | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 593b3fbe-a8de-1c09-e063-6294a90adc69 | 2026-08-24 | Warnings | M005 |
| Okkazhie WART REMOVER | 40% SALICYLIC ACID | Guangzhou Huixue Biotechnology Co., Ltd. | 59c2d759-d1e9-6c9d-e063-6294a90a04db | 2026-08-23 | Warnings | M005 |
| 1% ketoconazole anti dandruff | 1% KETOCONAZOLE ANTI DANDRUFF SHAMPOO | Fast Sold LLC | 7bb3598c-9597-4f3d-9a68-bd9565737928 | 2026-08-22 | Warnings | M005 |
| JELVOXA ANTIFUNGAL | UNDECYLENIC ACID | Wuhan Ruihengjie Technology Co., Ltd. | 59a2f16e-ef72-f1cb-e063-6394a90abb28 | 2026-08-22 | Warnings | M005 |
| Viachs ANTIFUNGAL Cream | MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 598b7e0c-c76d-2f56-e063-6394a90a7053 | 2026-08-21 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998329 | undecylenic acid 25 % Topical Solution | PSN | 31dd1fb8-e661-eae8-e063-6394a90ab5e8 | 1 |
| 998329 | undecylenic acid 250 MG/ML Topical Solution | SCD | 31dd1fb8-e661-eae8-e063-6394a90ab5e8 | 1 |
| 998329 | undecylenic acid 25 % Topical Solution | SY | 31dd1fb8-e661-eae8-e063-6394a90ab5e8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85308-002-01 | 85308000201 | 30 mL in 1 BOTTLE (85308-002-01) | 30 ml | 2025-04-03 | No | No | Historical |