SERYNTH Clotrimazole
- Product NDC
- 85248-101
- 11-digit product format
- 852480101
- Labeler code
- 85248
- Product ID
- 85248-101_5729a4d3-1503-946f-e063-6294a90a6384
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole1% Clotrimazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Jiangxi Yudexi Pharmaceutical Co., LTD
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-08
- Substance
- CLOTRIMAZOLE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- SERYNTH Clotrimazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOTRIMAZOLE | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G07GZ97H65 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 309367 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4a4b304a-1acc-9185-e063-6394a90a1176 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85248-101-01 | SERYNTH Clotrimazole | 30 g in 1 BOTTLE | CREAM | 30 | 1 | |
| 85248-101-02 | SERYNTH Clotrimazole | 60 g in 1 BOTTLE | CREAM | 60 | 1 |
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 |
|---|---|---|---|---|---|---|
| Cura Hongo Antifungal | CLOTRIMAZOLE | Pharmadel LLC | df031309-2778-00cf-e053-2a95a90a5eea | 2025-11-17 | Warnings | M005 |
| CharmTex All in One Antibacterial Shave Gel Body Wash | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | a7433f39-a8d9-4c78-864d-d7ef193a7daf | 2025-11-16 | Warnings | M005 |
| Mint Blast Foot and Shoe Antifungal | UNDECYLENIC ACID 10% | SANSAR, LLC | f7fcac19-7b72-4b7a-a28e-669a0eebec9c | 2025-11-15 | Warnings | M005 |
| Lavender Foot and Shoe Antifungal | UNDECYLENIC ACID 10% | SANSAR, LLC | 9db58924-a84d-4763-badb-b3aeb46e1ea6 | 2025-11-15 | Warnings | M005 |
| Citrus Detox Foot and Shoe Antifungal | UNDECYLENIC ACID 10% | SANSAR, LLC | 6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc | 2025-11-15 | Warnings | M005 |
| AlphaTip Nail Repair Pen | NAIL REPAIR PEN | Guangzhou Qiexiran Cosmetics Co., Ltd. | 435c7973-8a67-8f51-e063-6394a90af58f | 2025-11-11 | Warnings | M005 |
| Pharmlitalia Antifungal Medicated Body | TOLNAFTATE | Foshan Sugar Max Cosmetics CO.,Ltd | 399302d2-0da4-4167-8884-b34a9aba8686 | 2025-11-10 | Warnings | M005 |
| PerfectHeal Antifungal | CLOTRIMAZOLE | Zhejiang Dingtai Pharmaceutical Co., Ltd | d9750991-8f10-4d6b-8841-bea022d5ad73 | 2025-11-10 | Warnings | M005 |
| PiYanPing Antifungal | MICONAZOLE NITRATE | Zhejiang Dingtai Pharmaceutical Co., Ltd | 840364aa-d799-4163-a9e8-3f10c18f86ae | 2025-11-10 | Warnings | M005 |
| SKINHEAL ANTIFUNGAL | TOLNAFTATE | Zhejiang Dingtai Pharmaceutical Co., Ltd | 570ee9fb-a495-4a99-9215-0cd1bb2e0290 | 2025-11-10 | Warnings | M005 |
| HUA TUO XIAN GAO ANTIFUNGAL | CLOTRIMAZOLE | MADISON ONE ACME INC | e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d | 2025-11-10 | Warnings | M005 |
| Selan Antifungal | SELAN ANTIFUNGAL | Trividia Manufacturing Solutions, Inc | 8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29 | 2025-11-07 | Warnings | M005 |
| Fortinia Ultra | CLOTRIMAZOLE 1% | The Podiatree Company | 43065a59-fb81-b1c2-e063-6294a90a36e0 | 2025-11-07 | Warnings | M005 |
| MICOCLEAR | CLOTRIMAZOLE ANTIFUNGAL | Rising Pharma Holdings, Inc. | d75b7d3c-3f1c-47e1-8122-4645f56a444e | 2025-11-06 | Warnings | M005 |
| Medline | MICONAZOLE NITRATE | Medline Industries, LP | 1ea444eb-f2f5-8c63-e063-6294a90acac8 | 2025-11-06 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL POWDER SPRAY | Premier Brands of America Inc. | 38ccf19c-2290-ad99-e063-6394a90a5469 | 2025-11-06 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL POWDER SPRAY WITH BAKING SODA | Target Corporation | 37792b12-c3dc-558f-e063-6294a90a7e75 | 2025-11-06 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Topco Associates LLC | 5f8ae9ab-5e34-7a60-e053-2991aa0a9817 | 2025-11-06 | Warnings | M005 |
| Tolnaftate | TOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREE | Topco Associates LLC | 5f8ac6b7-c46c-226c-e053-2991aa0a9606 | 2025-11-06 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Topco Associates LLC | 3dd0df06-3c74-4c34-a69e-4240945f5fa5 | 2025-11-06 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309367 | clotrimazole 1 % Topical Cream | PSN | 4a4b304a-1acc-9185-e063-6394a90a1176 | 1 |
| 309367 | clotrimazole 10 MG/ML Topical Cream | SCD | 4a4b304a-1acc-9185-e063-6394a90a1176 | 1 |
| 309367 | clotrimazole 1 % Topical Cream | SY | 4a4b304a-1acc-9185-e063-6394a90a1176 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85248-101-01 | 85248010101 | 30 g in 1 BOTTLE (85248-101-01) | 30 g | 2026-02-08 | No | No | Current |
| 85248-101-02 | 85248010102 | 60 g in 1 BOTTLE (85248-101-02) | 60 g | 2026-02-08 | No | No | Current |