Tolnafate
- Product NDC
- 68016-653
- 11-digit product format
- 680160653
- Labeler code
- 68016
- Product ID
- 68016-653_4aa5f166-0e54-6d6c-e063-6394a90a8a62
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate Jock Itch Powder Spray - Talc Free
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-10-31
- Marketing end
- 2028-06-30
- Substance
- TOLNAFTATE
- Active strength
- 1.3 g/130g
- 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
- Tolnafate
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | 1.3 g/130g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06KB629TKV | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 705934 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-653-46 | Tolnafate | 130 g in 1 CAN | AEROSOL, SPRAY | 130 | 9 |
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 |
|---|---|---|---|---|---|---|
| Nailtific Daytime Treatment Antifungal Pen Refill | NAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILL | Guangzhou Meixi Biotechnology Co., Ltd. | 4257ee32-0d8f-08d4-e063-6294a90a4a89 | 2026-04-11 | Warnings | M005 |
| Nailtific Nighttime Antifungal Renewal Pen Refill | TOLNAFTATE | Guangzhou Meixi Biotechnology Co., Ltd. | 42634fc7-d0c7-4813-e063-6294a90a702d | 2026-04-11 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Chain Drug Marketing Association Inc | 1a4f4d10-6782-ddb4-e063-6294a90ac206 | 2026-04-09 | Warnings | M005 |
| Extra Strength Toenail Renewal Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eed68e6-6814-0181-e063-6394a90a888e | 2026-04-08 | Warnings | M005 |
| TAGOQHIA Extra Strength NAIL REPAIR PEN | TOLNAFTATE, UNDECYLENIC ACID | Guangzhou Borderless Technology Co., Ltd. | 4eefbef4-7643-dca4-e063-6394a90a72c1 | 2026-04-08 | Warnings | M005 |
| ZYNTHIX | UNDECYLENIC ACID SOLUTION | Shenzhen Siwei Yijiu Trading Co., Ltd. | 4ef4a167-f673-efb4-e063-6294a90a3026 | 2026-04-08 | Warnings | M005 |
| EXTRA STRENGTH TOENAIIL RENEWAL PEN | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eea5ee7-0ef9-8d34-e063-6294a90af595 | 2026-04-07 | Warnings | M005 |
| EXTRA STRENGTH TOENAIIL RENEWAL Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeaa2f0-efc7-eab3-e063-6294a90a13b3 | 2026-04-07 | Warnings | M005 |
| Extra Strength Toenail Renewal Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeb59d2-3891-2e45-e063-6294a90a4fcf | 2026-04-07 | Warnings | M005 |
| RoyceDerm Tinea ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4e889f2b-9ea1-b1a6-e063-6394a90a4654 | 2026-04-03 | Warnings | M005 |
| Dryello Tolnaftate 1% Antifungal | TOLNAFTATE | ProPedix, Inc. | 4e962ca4-80ee-a379-e063-6394a90a1322 | 2026-04-03 | Warnings | M005 |
| Toenail Fungus Treatment Extra Strength Pen | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6 | 2026-04-02 | Warnings | M005 |
| TOENAIL FUNGUS TREATMENT Liquid | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fc7049-e367-42bf-e063-6394a90a6f06 | 2026-04-02 | Warnings | M005 |
| Fungal Nail Patches | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 299a63ad-f321-117c-e063-6394a90a3a22 | 2026-04-02 | Warnings | M005 |
| Secura Antifungal Greaseless | MICONAZOLE NITRATE | Smith & Nephew Medical Ltd | 9be600e4-76ec-4071-a8ec-a0b23155271d | 2026-04-02 | Warnings | M005 |
| FifthPulse Bacitracin Zinc | BACITRACIN ZINC | WeCare Products LLC | 5c6b3ad8-c158-4cc0-b1ba-b829b5df1284 | 2026-04-02 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Antifungal | MICONAZOLE NITRATE | WeCare Products LLC | b70238eb-afcb-4e09-976f-973df249241c | 2026-04-02 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE | Hanyang Qisheng (Shenzhen) Technology Co., Ltd. | 4e85f338-ffd7-85b1-e063-6294a90a3c87 | 2026-04-02 | Warnings | M005 |
| RoyceDerm Anti-Fungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 4e861073-88e8-b2f7-e063-6394a90ab94a | 2026-04-02 | Warnings | M005 |
| Miconazole Nitrate | JOCK ITCH SPRAY | CVS Pharmacy | 7b70d3ea-126a-42aa-8509-b982893c710b | 2026-04-01 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 705934 | tolnaftate 1 % Powder Spray | PSN | 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | 9 |
| 705934 | tolnaftate 0.01 MG/MG Powder Spray | SCD | 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | 9 |
| 705934 | tolnaftate 1 % Powder Spray | SY | 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-653-46 | 68016065346 | 130 g in 1 CAN (68016-653-46) | 130 g | 2017-10-31 | 2028-06-30 | No | No | Current |