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 |
|---|---|---|---|---|---|---|
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | ASTONEA LABS PRIVATE LIMITED | e66191a6-0c3c-7319-e053-2a95a90aae84 | 2024-06-25 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | b63a3fe5-5684-41bc-ad6c-69c54e5b942d | 2024-06-20 | Warnings | M005 |
| THERA Antifungal Body | MICONAZOLE NITRATE | McKesson Medical-Surgical Inc. | 31096041-28c9-4b16-bbd1-dbadefd37505 | 2024-06-14 | Warnings | M005 |
| Antifungal Body | MICONAZOLE NITRATE | McKesson | 4fb9aece-0baa-475e-e054-00144ff8d46c | 2024-06-13 | Warnings | M005 |
| Secura Protective | ZINC OXIDE | Smith & Nephew Medical Ltd | b077aa64-49a3-42ee-abb3-88f833635b93 | 2024-06-12 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | NuCare Pharmaceuticals,Inc. | 627375fb-2f20-16bc-e053-2a91aa0a1542 | 2024-06-06 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Cardinal Health 110 dba LEADER | 199df107-3384-6e03-e063-6294a90afc38 | 2024-05-29 | Warnings | M005 |
| Femmesil | CLOTRIMAZOLE | Aidance Skincare & Topical Solutions, LLC | efddad82-9dc7-4cd9-b33c-7e85f30d992e | 2024-05-24 | Warnings | M005 |
| Anti-Fungal | MICONAZOLE NITRATE | Universal Distribution Center LLC | 8f316b0d-d308-4ae6-82c4-39bb0d1d474e | 2024-05-21 | Warnings | M005 |
| CANESPIES | TOLNAFTATE | OPMX LLC | e2f9eedc-3c43-416b-85b5-ba07fb5fb4db | 2024-05-17 | Warnings | M005 |
| Up and Up Antifungal | TOLNAFTATE 1% | Target Corporation | 8f54c8c7-6771-49c3-b429-53aa6df54dc5 | 2024-05-08 | Warnings | M005 |
| Up and Up Athletes Foot | CLOTRIMAZOLE 1% | Target Corporation | 52b61859-11ae-4990-aa0c-9dc1dd00adf4 | 2024-05-08 | Warnings | M005 |
| ADI Medical PVP-I Pouch, Foil | POVIDONE-IODINE | Asia Dynamics Inc., d/b/a ADI Medical | 0e8baf24-0c67-5511-e063-6394a90acaa1 | 2024-05-02 | Warnings | M005 |
| Caseys Antimicrobial Hand Sanitizer | ETHYL ALCOHOL | Navajo Manufacturing Company Inc. | 78863024-390c-4ff9-8ed6-02af07902a30 | 2024-04-29 | Warnings | M005 |
| MQUPIN Liquid Fungal Nail Treatment | LIQUID FUNGAL NAIL TREATMENT | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 14782f8c-3b29-1d88-e063-6294a90ac3e4 | 2024-03-25 | Warnings | M005 |
| ETADERM Advanced Antifungal Support | UNDECYLENIC ACID | NUEPHASE LLC | adb12a1c-ece9-4a59-a62c-89d212c57e6f | 2024-03-13 | Warnings | M005 |
| Dermachange Jock | MICONAZOLE NITRATE | Private label Beauty and Wellness | 12eef049-76c9-1450-e063-6394a90a00ea | 2024-03-05 | Warnings | M005 |
| Clotrimazole Antifungal | CLOTRIMAZOLE | Trifecta Pharmaceuticals USA, LLC. | 11bf50db-552e-0a39-e063-6394a90af60d | 2024-02-19 | Warnings | M005 |
| TOLNAFTATE ANTIFUNGAL | TOLNAFTATE | Bryant Ranch Prepack | fbbd159c-217e-46d3-963c-ba0bd1e9bbe8 | 2024-01-29 | Warnings | M005 |
| Target Jock Itch | CLOTRIMAZOLE 1% | Target Corporation | f44d4c44-99d1-413f-b9c3-8330bdd21abb | 2024-01-17 | 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 |