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 |
|---|---|---|---|---|---|---|
| Signature Select Advanced Hand Sanitizer | ALCOHOL | Living Better Brands LLC | 6d1cc25b-d612-4aae-bdb0-304758ef8f0f | 2026-01-26 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | Padagis Israel Pharmaceuticals Ltd | 3dcd0158-ec51-4fa7-a26a-02c2926156c0 | 2026-01-22 | Warnings | M005 |
| Puriya Antifungal Balm | ZINC UNDECYLENATE | IPC Republic, Inc. | 96bf44bc-b5eb-4198-9056-02e51665a162 | 2026-01-22 | Warnings | M005 |
| BZK Antiseptic | BENZALKONIUM CHLORIDE | Lights Medical Manufacture Co., Ltd. | 698ed472-9204-46e3-95a4-d59e204628ac | 2026-01-21 | Warnings | M005 |
| LIGHTS Swabstick | BENZALKONIUM CHLORIDE | Lights Medical Manufacture Co., Ltd. | 9346512e-53a1-420a-8b4d-bfbec32576a2 | 2026-01-21 | Warnings | M005 |
| Lights Isopropyl Alcohol Prep Pads | ISOPROPYL ALCOHOL | Lights Medical Manufacture Co., Ltd. | 4905a27c-6cf8-4b1a-a02c-4c81756e8c0a | 2026-01-21 | Warnings | M005 |
| Bee Venom Fungal Nail Treatment Liquid | BEE VENOM FUNGAL NAIL TREATMENT | Shenzhen Earth Surface Trading Co., Ltd. | 48d164bc-dab6-6fe4-e063-6394a90a3fc4 | 2026-01-20 | Warnings | M005 |
| Tolnaftate | MEIJER ATHLETES FOOT LIQUID SPRAY | Meijer Distribution Inc. | d9f7753f-aef9-86e2-e053-2995a90a2082 | 2026-01-20 | Warnings | M005 |
| Tolnaftate | FOOT ODOR CONTROL POWDER SPRAY | Meijer Distribution Inc | b3ba676e-9377-4665-b99e-d4143df96b36 | 2026-01-20 | Warnings | M005 |
| Tolnaftate | MEIJER ATHLETES FOOT LIQUID | Meijer Distribution Inc. | 0399dfef-9ea6-6fe4-e063-6394a90aec43 | 2026-01-20 | Warnings | M005 |
| TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid | TOLNAFTATE | Shenzhen Ctrip Technology Co., Ltd. | 1fb03184-5f21-c82a-e063-6294a90a9fa4 | 2026-01-19 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | AvKARE | 1a26534d-eeb8-8d17-e063-6294a90a70c7 | 2026-01-19 | Warnings | M005 |
| Hermon Antifungal Soap. 4 packs | TOLNAFTATE 1% | Beautivity LLC | 42c769de-f1e1-b3a1-e063-6394a90ab2a1 | 2026-01-18 | Warnings | M005 |
| Hermon Antifungal Cleansing Bar | TOLNAFTATE 1% | Beautivity LLC | 48b5d7b3-a134-ecdd-e063-6294a90a3213 | 2026-01-18 | Warnings | M005 |
| ANTIFUNGAL TOENAIL FUNGUS PEN | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 48b5fbd9-bdf5-21ac-e063-6394a90aa6b6 | 2026-01-18 | Warnings | M005 |
| Hermon Antifungal Soap. | TOLNAFTATE 1% | Beautivity LLC | 41e37014-549c-e592-e063-6294a90ac6ab | 2026-01-17 | Warnings | M005 |
| Hermon Antifungal .soap. | TOLNAFTATE 1% | Beautivity LLC | 482c338f-870f-f6d7-e063-6394a90a432c | 2026-01-17 | Warnings | M005 |
| MEOLY Fungal Nail Renewal | FUNGAL NAIL RENEWAL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 487d2e22-6328-893f-e063-6394a90a9dff | 2026-01-16 | Warnings | M005 |
| Lotrimin Antifungal | MICONAZOLE NITRATE | Bayer HealthCare LLC. | cebd222c-074f-443c-bd37-612114b27bbd | 2026-01-16 | Warnings | M005 |
| Lotrimin Daily Prevention | TOLNAFTATE | Bayer HealthCare LLC. | 9e8f9211-e85d-725a-e053-2995a90a09b3 | 2026-01-16 | 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 |