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 |
|---|---|---|---|---|---|---|
| Triple Antifungal | MICONAZOLE NITRATE | Advantice Health, LLC | 9a47fb1b-a41f-4c8a-8e43-7332853c308e | 2026-03-19 | Warnings | M005 |
| Antifungal | CLOTRIMAZOLE | Dynarex Corporation | 4d4cc4b4-c0b4-9e25-e063-6294a90a70b8 | 2026-03-18 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Dynarex Corporation | 4d384385-f3c5-09ba-e063-6394a90aec7f | 2026-03-17 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | e21ccb83-54ff-4605-80bf-7b4b789c7cb7 | 2026-03-17 | Warnings | M005 |
| Peunitory Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 4d2e86bc-5122-ba4a-e063-6394a90acf13 | 2026-03-16 | Warnings | M005 |
| DRMITSUI FOOT ANTIFUNGAL TREATMENT | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 4ce59d31-56fe-d74f-e063-6294a90a7cce | 2026-03-14 | Warnings | M005 |
| NERANTE FUNGUS NAIL PEN | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3984b-53cd-a665-e063-6394a90afe5f | 2026-03-13 | Warnings | M005 |
| FUNGAL NAIL TREATMENT | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3f0e2-b532-b89f-e063-6294a90a7e25 | 2026-03-13 | Warnings | M005 |
| BYT BANGYTONG HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shenzhen Jindali Technology Co., Ltd | 49ed1cc8-e8e5-399c-e063-6394a90a044a | 2026-03-10 | Warnings | M005 |
| Natouch Antifungal Wipes Plus | ANTIFUNGAL ANTISEPTIC WIPES PLUS | Natouch LLC | a85cb307-b3ad-1584-e053-2995a90a9a70 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb6fdfd-116e-14e9-e063-6294a90a4de3 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b | 2026-03-10 | Warnings | M005 |
| SootheSense Toenail Fungus Treatment | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ca2bbeb-3b8a-9482-e063-6294a90a5789 | 2026-03-09 | Warnings | M005 |
| Natouch Antifungal Antiseptic Wipes | ANTIFUNGAL ANTISEPTIC WIPES | Natouch LLC | 4c84c556-8d0b-ec28-e063-6294a90af1d3 | 2026-03-08 | Warnings | M005 |
| ANTIFUNGAL Cream | ANGELICA DAHURICA EXTRACTT, ASIATIC ACID | Guangzhou Mizi Biotechnology Co., LTD. | 4c586cd9-d356-34d8-e063-6294a90a4d11 | 2026-03-06 | Warnings | M005 |
| FungiFoam | TOLNAFTATE | The Tetra Corporation | 2449e8e5-9d7e-4119-9e7a-378efe55f875 | 2026-03-06 | Warnings | M005 |
| RoyceDerm ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4c43e62b-9060-8962-e063-6394a90aff63 | 2026-03-05 | Warnings | M005 |
| Derman Antifungal | TOLNAFTATE | Compania Internacional de Comercio, S.A.P.I. de C.V. | 5784a783-1056-4d50-8d87-2df4f8e16b09 | 2026-03-05 | Warnings | M005 |
| Antifungal Powder | TOLNAFTATE | ARMY & AIR FORCE EXCHANGE SERVICE | 4c39e121-4919-a482-e063-6294a90a98cd | 2026-03-04 | Warnings | M005 |
| ViLLsure Antifungal Pen | UNDECYLENIC ACID 25%ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c28cf04-94ad-8db6-e063-6394a90a2eed | 2026-03-03 | 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 |