Home NDC 76986-025 Gembooxt Ketoconazole 1% Medicated Shampoos
Product NDC 76986-025
11-digit product format 769860025
Labeler code 76986
Product ID 76986-025_49965e91-43c4-65d7-e063-6294a90abaec
Type HUMAN OTC DRUG
Nonproprietary name KETOCONAZOLE
Dosage form LIQUID
Route TOPICAL
Labeler Guangdong Quadrant Ecological Technology Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-30
Substance KETOCONAZOLE
Active strength .01 g/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 Additional Listing Data#
Finished product Yes
Brand name base Gembooxt Ketoconazole 1% Medicated Shampoos
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE .01 g/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 76986-025-01 Gembooxt Ketoconazole 1% Medicated Shampoos 300 mL in 1 BOTTLE LIQUID 300 1 76986-025-02 Gembooxt Ketoconazole 1% Medicated Shampoos 450 mL in 1 BOTTLE LIQUID 450 1 76986-025-03 Gembooxt Ketoconazole 1% Medicated Shampoos 750 mL in 1 BOTTLE LIQUID 750 1
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 1 of 1 · 1 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 76986-025-01 76986002501 300 mL in 1 BOTTLE (76986-025-01) 300 ml 2026-01-30 No No Current 76986-025-02 76986002502 450 mL in 1 BOTTLE (76986-025-02) 450 ml 2026-01-30 No No Current 76986-025-03 76986002503 750 mL in 1 BOTTLE (76986-025-03) 750 ml 2026-01-30 No No Current