Home NDC 87681-009-02 Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos
Product NDC 87681-009
Requested package NDC 87681-009-02
11-digit product format 876810009
Labeler code 87681
Product ID 87681-009_5792eff5-632f-3664-e063-6394a90a8ae3
Type HUMAN OTC DRUG
Nonproprietary name KETOCONAZOLE
Dosage form LIQUID
Route TOPICAL
Labeler Guangzhou Xinhongda Trading Service Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-27
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 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 Gemachlich ZuHause Ketoconazole 1% Anti-dandruff 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87681-009-02 87681000902 1 BOTTLE in 1 BOX (87681-009-02) / 750 mL in 1 BOTTLE 1 bottle 2026-07-27 No No Current