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 | ATHLETES FOOT POWDER SPRAY TALC FREE | Chain Drug Marketing Association | 327095bd-a7c9-291d-e063-6394a90afafa | 2026-06-09 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Chain Drug Marketing Association | 34b5c11f-710f-60e4-e063-6394a90a990d | 2026-06-09 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Marketing Association | 342affe8-0a4d-6fe6-e063-6394a90a8dad | 2026-06-09 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Chain Drug Marketing Association | edc2da26-ae46-4175-86ed-83e1a65f6d14 | 2026-06-09 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Chain Drug Marketing Association | aa97d2ca-bcf4-3ee1-e053-2a95a90a748d | 2026-06-09 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Marketing Association | 1bd8e096-1717-4656-b52c-086d2f56f070 | 2026-06-09 | Warnings | M005 |
| BODYKOO JOCK ITCH Cream | CLOTRIMAZOLE1% JOCK ITCH CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 53553b31-81bb-d293-e063-6294a90aa0a5 | 2026-06-09 | Warnings | M005 |
| BODYKOO ATHLETE FOOT Cream | MICONAZOLE NITRATE2% ATHLETE FOOT CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 53561903-54fe-f8ec-e063-6294a90a19fe | 2026-06-09 | Warnings | M005 |
| Clotrimazole Cream | CLOTRIMAZOLE USP1% | Aldermed Inc. | 53bdd76b-6290-f1d3-e063-6394a90a9ff1 | 2026-06-08 | Warnings | M005 |
| Miconazole Cream | MICONAZOLE NITRATE | Aldermed Inc. | 4a7fc48a-c103-dc84-e063-6394a90ab80f | 2026-06-08 | Warnings | M005 |
| Antifungal Powder | MICONAZOLE NITRATE | Aldermed Inc. | 60954089-5220-4f4c-8595-b5ee4562562c | 2026-06-08 | Warnings | M005 |
| Jock Itch Powder | MICONAZOLE NITRATE | Walgreens Company | 06d2f36c-8615-af08-e063-6394a90aa424 | 2026-06-05 | Warnings | M005 |
| Miconazole Nitrate 2% | JOCK ITCH SPRAY | Walgreens Company | cf6cbaf4-beba-6fdf-e053-2995a90a76d2 | 2026-06-04 | Warnings | M005 |
| Charmpoo Antifungal Cream | MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 5368b131-7537-8679-e063-6394a90a6754 | 2026-06-04 | Warnings | M005 |
| Nail Fungus Treatment Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3fe842e1-b3db-c003-e063-6394a90a46b8 | 2026-06-04 | Warnings | M005 |
| Lasolex AC | MICONAZOLE NITRATE 2% ANTIFUNGAL | PureTek Corporation | 52bb4bc1-e88f-f5ea-e063-6394a90ae1e8 | 2026-06-03 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Sun Pharmaceutical Industries, Inc. | 13a14d3c-bfce-42b5-8463-4ec69e94774e | 2026-06-03 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 43cbad59-9899-ab3b-e063-6294a90a9e12 | 2026-06-02 | Warnings | M005 |
| Athletes Foot Cream | CLOTRIMAZOLE | Shenzhen Miandou Technology Co.,Ltd. | 53451e74-719e-9499-e063-6394a90a9e5a | 2026-06-02 | Warnings | M005 |
| Lasolex AL | MICONAZOLE NITRATE 2% ANTIFUNGAL | PureTek Corporation | 534df9be-b47a-03a1-e063-6394a90a265a | 2026-06-02 | 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 |