Home NDC 85384-0002 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 table Ingredient Strength KETOCONAZOLE 10 mg/1000g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9400W927I Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 48 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVERLIT CARE Hand Sanitizer ETHYL ALCOHOL EVERLIT GLOBAL INC. b9909c59-02e7-4d6c-aa2b-206f1ab4d02c 2023-11-14 Warnings Exact identifier application number: M005 FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID Triple Point Group, LLC 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5 2023-11-11 Warnings Exact identifier application number: M005 SIMPLY VITAL Antifungal Cream CLOTRIMAZOLE ALPHA PLANTS INC d3842de3-0d13-4dc2-920b-90a4b822bbb8 2023-11-11 Warnings Exact identifier application number: M005 CLARUS AC Antifungal Solution TOLNAFTATE Clinical Therapeutic Solutions 28ab9f1b-65cd-4405-a9a3-f3c9b836693d 2023-11-10 Warnings Exact identifier application number: M005 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) 2c966d97-30f5-4942-b64d-742884ce6a2f 2023-11-10 Warnings Exact identifier application number: M005 Smooth Gator Fungus Eliminator CLOTRIMAZOLE Smooth Gator, LLC 262b04f5-1b5d-4c67-a557-01f8b1711302 2023-11-10 Warnings Exact identifier application number: M005 TOLNAFTATE ANTIFUNGAL TOLNAFTATE Geri-Care Pharmaceuticals, Corp f9e60430-eec1-4bc2-9522-eb5aa527d90a 2023-11-08 Warnings Exact identifier application number: M005 Terrasil Jock Itch Treatment Maximum Strength CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC c62fbf23-5d19-44ab-9c1a-e9b803192ed0 2023-11-08 Warnings Exact identifier application number: M005 terrasil The Fungal Solution Kit CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 9a5eb581-62a2-41fe-a174-e852fc47e235 2023-11-08 Warnings Exact identifier application number: M005 EmoniNail Antifungal UNDECYLENIC ACID GG Healthworks Inc. 84ace47a-d3ae-4735-87b6-dbbf1c40cf54 2023-11-06 Warnings Exact identifier application number: M005 CIDACIN Antifungal Treatment TOLNAFTATE Pedicis Research LLC bd53a9e3-65c8-4834-8e23-a2a928b83a66 2023-11-05 Warnings Exact identifier application number: M005 MacerRx Web MICONAZOLE NITRATE Clinical Therapeutic Solutions c9327f41-10f1-41f3-855b-838c701d6767 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 7e8897ff-67d1-4336-866e-cb76a36edddc 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 308a91d1-3511-4e2d-a62f-a31d77d70e06 2023-11-05 Warnings Exact identifier application number: M005 Human Science Antifungal Foot Care UNDECYLENIC ACID HUMAN SCIENCE, LLC 26b2519b-7d7b-4b33-b5d6-a41fe6f73538 2023-11-05 Warnings Exact identifier application number: M005 HomeHealth Antifungal TOLNAFTATE Home Health 895cd24c-3f78-4e2e-bf98-8bb6605798da 2023-11-05 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Proficient Rx LP 800a9dab-d287-427e-af6d-26996e0def41 2023-11-01 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE-IODINE Dr Radows 58e1757c-45ce-455e-bd64-a9e99cd3680f 2023-10-30 Warnings Exact identifier application number: M005 JOCK-EZE CLOTRIMAZOLE Bentlin Products LLC d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280 2023-10-30 Warnings Exact identifier application number: M005 TheraPlus Plus CLOTRIMAZOLE Zhejiang Jingwei Pharmaceutical Co., Ltd. de75179d-1889-4823-9f39-4bebdf185d76 2023-10-27 Warnings Exact identifier application number: M005
Packages# Package NDC, 11-digit format, Description table 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