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 |
|---|---|---|---|---|---|---|
| Unishield Hand Sanitizer | ETHYL ALCOHOL | Unishield | eae1fc97-eb39-4353-adfa-7c549d50b5db | 2025-09-24 | Warnings | M005 |
| RUGBY ANTIFUNGAL CLOTRIMAZOLE | CLOTRIMAZOLE | Rugby Laboratories | 0b32a369-ea1c-4cb8-8ea1-07bba8f16b72 | 2025-09-16 | Warnings | M005 |
| SKIN TAG WART AND CORN REMOVER | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 3e6dad69-b301-f7dc-e063-6394a90ad380 | 2025-09-14 | Warnings | M005 |
| FUNGAL NAILS REPAIRING ESSENCE | PEPPERMINT OIL | Zhenping Renren Industry Co., Ltd. | 3e82649c-d784-d64c-e063-6294a90ac95d | 2025-09-11 | Warnings | M005 |
| equate Athletes Foot | TOLNAFTATE | Wal-Mart Stores Inc | e90297d0-0f87-4ae3-b9b7-959266d57c24 | 2025-09-11 | Warnings | M005 |
| Bee Venom Toenail Fungus Treatment | BEE VENOM TOENAIL FUNGUS TREATMENT | Shenzhen Earth Surface Trading Co., Ltd. | 3e7d22b0-2f57-fcac-e063-6394a90aefd9 | 2025-09-10 | Warnings | M005 |
| Amerfresh Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | cdc4f0ff-07bd-47c8-850b-1698308bb660 | 2025-09-09 | Warnings | M005 |
| Antifungal Cream | MICONAZOLE NITRATE | Encube Ethicals, Inc. | 8be4bbfa-424c-4ccf-b8bc-65b16c126053 | 2025-09-04 | Warnings | M005 |
| ANTIFUNGAL | CLOTRIMAZOLE | Encube Ethicals, Inc. | afbc28f8-bb76-424d-9d73-136e6c283ead | 2025-09-04 | Warnings | M005 |
| Hermon Balanitis relief kit | SULFUR 1X HPUS | Beautivity LLC | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 2025-09-02 | Warnings | M005 |
| Extra Strength Nail Fungus Treatment | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3abc0892-e52b-a40f-e063-6294a90a0e35 | 2025-09-02 | Warnings | M005 |
| Hermon Balanitis Cream | SULFUR 1X HPUS | Beautivity LLC | 3dba4e4b-8224-6a96-e063-6394a90a9129 | 2025-09-01 | Warnings | M005 |
| Caseys | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | a29d6c19-01aa-45b0-92cd-3f1148bad4f8 | 2025-08-30 | Warnings | M005 |
| Tolnafate | TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE | VALU MERCHANDISERS, CO. | 1d258684-9034-460c-953d-78e2b5198167 | 2025-08-26 | Warnings | M005 |
| Femmesil Maximum Strength | MICONAZOLE NITRATE | Aidance Skincare & Topical Solutions, LLC | d8b01fe1-4465-497b-909e-f51f31fdf833 | 2025-08-25 | Warnings | M005 |
| femmesil Ultra Therapy | CLOTRIMAZOLE | Aidance Scientific, Inc. | 3d36794a-07d0-860c-e063-6294a90a6e8f | 2025-08-25 | Warnings | M005 |
| Nedtol Folliculitis Treatment Creams | MICONAZOLE NITRATE | Jiashen International Trade Limited | 3d0a1e39-82e4-9337-e063-6294a90aa9a3 | 2025-08-23 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | 6b74d405-42d6-4c46-ba78-3007d1e8ffb8 | 2025-08-23 | Warnings | M005 |
| FUNGLARA Anti Fungal | UNDECYLENIC ACID | FUNGLARA LLC | a23c2399-36ea-4f22-8140-066e22c9a862 | 2025-08-20 | Warnings | M005 |
| Rapid MicroGel | TOLNAFTATE | The Tetra Corporation | afb6d7c4-1f75-4694-83c8-d6469250d6a1 | 2025-08-19 | 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 |