Home NDC 85384-0001 1% ketoconazole
Product NDC 85384-0001
11-digit product format 853840001
Labeler code 85384
Product ID 85384-0001_1b9d0aa4-ace1-48b8-a76f-ddf34c238320
Type HUMAN OTC DRUG
Nonproprietary name Ketoconazole
Dosage form SHAMPOO
Route TOPICAL
Labeler TAGRID LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-31
Substance KETOCONAZOLE
Active strength 10 mg/mL
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 1% ketoconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 10 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240812 Internal RxNorm 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 85384-0001-1 1% ketoconazole 250 mL in 1 BOTTLE SHAMPOO 250 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85384-0001 1% KETOCONAZOLE (KETOCONAZOLE) SHAMPOO [TAGRID LLC] 1 Current NDC, 1 package rows 20250331_30b75584-3a1e-c125-e063-6294a90acaa7.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 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85384-0001-1 85384000101 250 mL in 1 BOTTLE (85384-0001-1) 250 ml 2025-03-31 No No Current