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 |
|---|---|---|---|---|---|---|
| Maximum Strength Antifungal Liquid | TOLNAFTATE | FSA Store Inc. | fae36294-68b6-bf14-e053-6394a90aaacd | 2025-10-27 | Warnings | M005 |
| EVERLIT CARE Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 58dd955e-e68b-4fbd-90c8-a85b15c00dc7 | 2025-10-25 | Warnings | M005 |
| EVERLIT CARE Hand Sanitizer | ETHYL ALCOHOL | EVERLIT GLOBAL INC. | 1360cdd8-b2b2-4af9-b6ff-af1101d49e18 | 2025-10-25 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Better Living Brands LLC | ccff8d63-ee7d-eada-e053-2995a90ac5dd | 2025-10-24 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Better Living Brands LLC | ccff4830-6d81-2a0d-e053-2a95a90a154c | 2025-10-24 | Warnings | M005 |
| Liquid Antifungal Treatment | TOLNAFTATE | Hudson Health LLC | 14a9efd8-e49f-12fa-e063-6394a90aa8a0 | 2025-10-24 | Warnings | M005 |
| Miconazole Nitrate | ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE | Hudson Health LLC | 36ec5f05-5d1c-25df-e063-6394a90a9dd9 | 2025-10-24 | Warnings | M005 |
| Signature Care Antifungal Cream Tolnaftate 1% | TOLNAFTATE | BETTER LIVING BRANDS LLC | b02b81d6-8db4-927b-e053-2995a90a3958 | 2025-10-24 | Warnings | M005 |
| Winco Foods Tolnaftate | TOLNAFTATE | Winco Foods, LLC | 218f7613-1401-4f1b-bf46-576b536825af | 2025-10-23 | Warnings | M005 |
| zourunan MULTI-PURPOS TREATMENT | MULTI-PURPOS TREATMENT | Guchutang Biotechnology (Longyan) Co., Ltd | 41bad254-b674-9521-e063-6294a90ab634 | 2025-10-22 | Warnings | M005 |
| zourunan FOOT ODOR PROBIOTIC | FOOT ODOR | Guchutang Biotechnology (Longyan) Co., Ltd | 41bbc02c-53f2-2d94-e063-6394a90ac9ec | 2025-10-22 | Warnings | M005 |
| Signature Care Athletes Foot | CLOTRIMAZOLE | Safeway | c1750c17-4afb-aecf-e053-2a95a90af35b | 2025-10-22 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Imperial Feet B.V. | 1189c7d8-7c8f-ae01-e063-6294a90ac270 | 2025-10-21 | Warnings | M005 |
| Fungicure Liquid Gel | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | dfd03852-29bd-4e16-97f3-64dfde5f8ff8 | 2025-10-21 | Warnings | M005 |
| Athlete Foot Medicated bar | TOLNAFTATE | Beautivity LLC | 3b2cedb2-18f4-f571-e063-6394a90a6418 | 2025-10-21 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Quantum, Inc. | 6cb95707-9831-41f1-a23e-9e3356141fdc | 2025-10-20 | Warnings | M005 |
| Toe Fungus | TOLNAFTATE | Imperial Feet B.V. | 118a6c97-4e8a-050a-e063-6294a90a1108 | 2025-10-17 | Warnings | M005 |
| Inlifay ANTIFUNGAL | TOLNAFTATE | Guangzhou Haishi Biological Technology Co., Ltd. | 4141574d-7a5b-c437-e063-6394a90aacb6 | 2025-10-16 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | HY-VEE, INC | 415ecf9b-460d-82b6-e063-6294a90a0e05 | 2025-10-16 | Warnings | M005 |
| SEACALL NAIL REVIVE SERUM | NAIL REVIVE SERUM | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f4d0c9a-361e-72e5-e063-6394a90a7cda | 2025-10-15 | 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 |