Tagrit Antifungal Treament Ketoconazole 1%
- Product NDC
- 85384-0002
- 11-digit product format
- 853840002
- Labeler code
- 85384
- Product ID
- 85384-0002_a42bf040-8183-4a90-bf21-4596f5eacfc5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- TAGRID LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-18
- Substance
- KETOCONAZOLE
- Active strength
- 10 mg/1000g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- 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
- Tagrit Antifungal Treament Ketoconazole 1%
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| KETOCONAZOLE | 10 mg/1000g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R9400W927I | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 315a8832-c42f-c07a-e063-6394a90a8218 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5 | Product name | 2 | 20250331 |
| 1e18fb2e-aeff-8efe-93be-5a5f7be8faa2 | Product name | 2 | 20211209 |
| 8bc3781f-20ed-678b-44a7-a981e693c65f | Product name | 2 | 20211209 |
| ff3a8c91-648c-300b-467e-10703f514265 | Product name | 2 | 20180809 |
| 152a96a4-36b6-f5b1-d4e6-9a500e06bbf3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85384-0002-1 | Tagrit Antifungal Treament Ketoconazole 1% | 100 g in 1 TUBE | CREAM | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85384-0002 | TAGRIT ANTIFUNGAL TREAMENT KETOCONAZOLE 1% (KETOCONAZOLE) CREAM [TAGRID LLC] | 1 | Current NDC, 1 package rows | 20250418_315a8832-c42f-c07a-e063-6394a90a8218.zip |
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85384-0002-1 | 85384000201 | 100 g in 1 TUBE (85384-0002-1) | 100 g | 2025-04-18 | No | No | Current |