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 |
|---|---|---|---|---|---|---|
| Clotrimazole | CLOTRIMAZOLE | AvPAK | 3ca3b475-7b69-442a-e063-6294a90a7b3f | 2025-08-18 | Warnings | M005 |
| Formula 3 | TOLNAFTATE | The Tetra Corporation | 0895274b-a09d-4264-a43f-852e44eb3163 | 2025-08-18 | Warnings | M005 |
| Formula 7 - The Solution | TOLNAFTATE | The Tetra Corporation | 18619649-7f79-4b6e-8b7c-69d70365d557 | 2025-08-18 | Warnings | M005 |
| GlyCylic | SALICYLIC ACID | The Tetra Corporation | 501d3ba9-ba42-4c1c-983b-492adaee039d | 2025-08-18 | Warnings | M005 |
| SupreH Ringworm Treatment Balm | SUPREH RINGWORM TREATMENT BALM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3c77222b-d92e-84b0-e063-6294a90aadd7 | 2025-08-16 | Warnings | M005 |
| OetMoe Antifungal Solution | OETMOE ANTIFUNGAL SOLUTION | Shenzhen Earth Surface Trading Co., Ltd. | 3c26d917-4186-6f02-e063-6394a90a99f6 | 2025-08-12 | Warnings | M005 |
| Cureforte Anti Fungal Foot Care | ANTI FUNGAL FOOT CARE DROPS | STEEL CITY HEALTH PRIVATE LIMITED | 39f762a6-9d0c-8ded-e063-6394a90a3659 | 2025-08-11 | Warnings | M005 |
| Derman Antifungal Powder Tolnaftate | TOLNAFTATE | Taisho Pharmaceutical California Inc. | 3a854765-740c-4719-8abf-4b3f932cdee0 | 2025-08-07 | Warnings | M005 |
| Derman antifungal cream | TOLNAFTATE | Taisho Pharmaceutical California Inc. | 15d9b3c9-01af-4083-a1bc-014505d8798d | 2025-08-07 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Hudson Health LLC | 24b22794-f9f8-6f32-e063-6394a90aec98 | 2025-08-07 | Warnings | M005 |
| Toe Area Treatment | TOLNAFTATE | CVS | 17681cc8-fbb1-a0cf-e063-6294a90add18 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Family Dollar Services, Inc | 178e7b3f-949f-3f51-e063-6294a90a9395 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | LEADER/Cardinal Health 110, Inc. | 17695563-3765-74cb-e063-6294a90a6120 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Target Corporation | 1dff278f-47bc-459a-e063-6394a90a2646 | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | TopCo Associates | 19c268a1-7b2e-63c9-e063-6394a90acddc | 2025-08-07 | Warnings | M005 |
| Antifungal Liquid Maximum Strength | TOLNAFTATE | Walgreens Company | 137eabb7-cb4f-1631-e063-6294a90ab847 | 2025-08-07 | Warnings | M005 |
| WCTNGO Fungal Nail Treatment Swabs | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3bad0d73-b33d-b962-e063-6294a90a7ba7 | 2025-08-06 | Warnings | M005 |
| ONIADBA Nail Fungus Treatment Pen | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3bad19f1-d5b3-c5de-e063-6294a90a0c03 | 2025-08-06 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Premier Brands of America Inc | 2644ba07-aaee-6402-e063-6394a90a2827 | 2025-08-06 | Warnings | M005 |
| Anti- Fungal Miconazole Nitrate | MICONAZOLE NITRATE | Premier Brands of America Inc. | f186bdc1-db6c-0fab-e053-2995a90a7c58 | 2025-08-06 | 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 |