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 |
|---|---|---|---|---|---|---|
| TopCare Antifungal Maximum Strength | UNDECYLENIC ACID | TOPCO ASSOCIATES LLC | 7c44fb4e-0eef-4ced-b03f-a02ebe6c0264 | 2025-12-22 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | a3ae043b-dc97-449b-b099-70bdf8e92482 | 2025-12-19 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | RUGBY LABORATORIES | 6de9155b-7070-38fd-e053-2a91aa0af6f6 | 2025-12-19 | Warnings | M005 |
| HC Max Anti-Fungal | TOLNAFTATE | Kramer Laboratories | ee99cd87-549f-4a43-878e-b4d5935de0e0 | 2025-12-19 | Warnings | M005 |
| Fungi Nail Anti-Fungal Pen | TOLNAFTATE | Kramer Laboratories | 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3 | 2025-12-19 | Warnings | M005 |
| Tolnaftate | FOOT ODOR CONTROL POWDER SPRAY | Winco Foods, LLC | cc257a18-247f-c787-e053-2a95a90a075a | 2025-12-16 | Warnings | M005 |
| Tolnaftate | ODOR CONTROL POWDER SPRAY | Walgreen Company | a113f568-bd20-4f02-8e09-1b8223a0a9fa | 2025-12-16 | Warnings | M005 |
| Tobcharm Toenail Fungus Treatment Liquid | TOENAIL FUNGUS TREATMENT LIQUID | Guangzhou Qiexiran Cosmetics Co., Ltd. | 45f92be2-0677-5989-e063-6394a90af280 | 2025-12-15 | Warnings | M005 |
| TEA TREE Oil ANTIFUNGAL Cream | ZINC UNDECYLENATE, UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 45bd3ad0-a0d1-314f-e063-6394a90a9a3a | 2025-12-12 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Topco Associates LLC | 97334166-1dff-4ed2-ad31-f524b22097f9 | 2025-12-12 | Warnings | M005 |
| Foot Odor Control Powder | TOLNAFTATE | Meijer Distribution Inc | 03fd2680-0040-aa8c-e063-6294a90a090f | 2025-12-12 | Warnings | M005 |
| Foot Odor Control Powder | TOLNAFTATE | Premier Brands of America Inc. | edb0a2da-aaa1-3b9b-e053-2995a90a5012 | 2025-12-12 | Warnings | M005 |
| Pedikleer | TOLNAFTATE | Rising Pharma Holdings, Inc. | 83396c51-7107-4d98-9d80-ebf6584f4dc8 | 2025-12-11 | Warnings | M005 |
| ELAIMEI FUNGAL NAIL PATCHES | TEA TREE OIL | Shenzhen Shandian Jingling Technology Co., Ltd. | 457d08eb-e812-8f12-e063-6294a90ab85f | 2025-12-10 | Warnings | M005 |
| Lofuanna FUNGAL NAIL PATCHES | TEA TREE OIL | Shenzhen Shandian Jingling Technology Co., Ltd. | 43da9ec2-5f2f-dfce-e063-6394a90aecca | 2025-12-10 | Warnings | M005 |
| WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25% | UNDECYLENIC ACID 25% | Shenzhen Shandian Jingling Technology Co., Ltd. | 457f819b-0850-a97c-e063-6394a90ac368 | 2025-12-09 | Warnings | M005 |
| NAIL REPAIR PEN | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 45814b84-0e51-6c9d-e063-6394a90a2905 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAY | Better Living Brands | ccfef81b-f271-4551-e053-2a95a90a8ac4 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE | Foodhold USA | a64c9371-0ac7-4c47-bc12-7bc77162b244 | 2025-12-09 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Harris Teeter, LLC | 02eb9c78-5a89-4958-b5a4-68f39e584cf2 | 2025-12-09 | 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 |