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 |
|---|---|---|---|---|---|---|
| ONIADBA Fungal Nail Treatment Swabs | TOLNAFTATE,UNDECYLENIC ACID | Shenzhen Boyimei Technology Co., Ltd. | 3baa99ab-6d22-8d7d-e063-6294a90af3e8 | 2025-08-05 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | cca84334-2e2d-4991-9d1e-d5b7c9ffd392 | 2025-08-01 | Warnings | M005 |
| RoyceDerm CoolDefense Refreshing Shower Gel | TOLNAFTATE 1.0% | RoyceDerm LLC | 3b3216d6-8cc8-ea89-e063-6294a90ab691 | 2025-07-31 | Warnings | M005 |
| SUNMARK MICONAZOLE NITRATE antifungal | MICONAZOLE NITRATE | Strategic Sourcing Services LLC | 7c15d95a-5b89-4789-8c91-3f61d7ec7707 | 2025-07-30 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Advanced Rx LLC | e13eb653-3916-444a-ae86-1738c0308b79 | 2025-07-28 | Warnings | M005 |
| Meridian Unwrapped Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Yangzhou Hongshengding Chemical Co.,Ltd. | a2b9570f-312c-4f46-994d-efe057b247aa | 2025-07-28 | Warnings | M005 |
| Meridian Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Yangzhou Hongshengding Chemical Co.,Ltd. | b41b130f-48fd-47d4-a94e-74433ae44de2 | 2025-07-28 | Warnings | M005 |
| Rugby Clotrimazole Antifungal Cream | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | bd567e91-7152-4612-83e0-8e8a00c2d2c5 | 2025-07-25 | Warnings | M005 |
| Hongocura | UNDECYLENIC ACID, ZINC UNDECYLENATE | MENPER DISTRIBUTORS, INC. | c69b735e-0ffe-4328-bd9f-3c1ac6798c08 | 2025-07-22 | Warnings | M005 |
| Hongocura Pinceladas | UNDECYLENIC ACID | Menper Distributors, Inc. | 4b9a3a70-d646-47c6-b969-5c4d759d23a4 | 2025-07-22 | Warnings | M005 |
| Hongocura M | UNDECYLENIC ACID | MENPER DISTRIBUTORS, INC. | b4adb7b0-59b4-4b3c-9b0e-1869bb543174 | 2025-07-22 | Warnings | M005 |
| Hongocura S | UNDECYLENIC ACID | MENPER DISTRIBUTORS, INC. | 4a21f371-bfc1-4e66-af16-55b3283872b7 | 2025-07-22 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Cream 1oz | MICONAZOLE NITRATE | Front Pharmaceutical PLC | 3a37a3a8-9d05-926c-e063-6294a90a9ed8 | 2025-07-18 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Cream 4oz | MICONAZOLE NITRATE | Front Pharmaceutical PLC | 3a382b79-dde9-dde0-e063-6294a90a53bb | 2025-07-18 | Warnings | M005 |
| FifthPulse clotrimazole cream 4oz | CLOTRIMAZOLE 1% | Front Pharmaceutical PLC | 3a389093-48f2-29cb-e063-6294a90ada37 | 2025-07-18 | Warnings | M005 |
| PHARMBANNER Tea Tree Oil Antifungal Soap. | TEA TREE OIL ANTIFUNGAL SOAP. | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a0860b0-346e-7024-e063-6394a90ace81 | 2025-07-16 | Warnings | M005 |
| TopCare Antifungal | CLOTRIMAZOLE | Topco Associates LLC | 6757eb2a-73e0-4bd0-a332-5713fdf3445d | 2025-07-16 | Warnings | M005 |
| UpandUp Clotrimazole | CLOTRIMAZOLE | Target Corporation | cb2b7d38-9988-493b-9843-56c2f59eed2f | 2025-07-16 | Warnings | M005 |
| Jock Itch | CLOTRIMAZOLE | TARGET Corporation | 1ae551e7-69de-4eef-b4f7-5e1a880e631d | 2025-07-16 | Warnings | M005 |
| Athletes Foot | CLOTRIMAZOLE | FRED'S, INC. | d2d8f44e-2dfa-446b-855e-86e0d6d2d0df | 2025-07-15 | 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 |