FDA.reportPublic FDA data

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
IngredientStrength
KETOCONAZOLE.01 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui240812

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-025-01Gembooxt Ketoconazole 1% Medicated Shampoos300 mL in 1 BOTTLELIQUID3001
76986-025-02Gembooxt Ketoconazole 1% Medicated Shampoos450 mL in 1 BOTTLELIQUID4501
76986-025-03Gembooxt Ketoconazole 1% Medicated Shampoos750 mL in 1 BOTTLELIQUID7501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240812ketoconazole 1 % Medicated ShampooPSN49965e91-43c3-65d7-e063-6294a90abaec1
240812ketoconazole 10 MG/ML Medicated ShampooSCD49965e91-43c3-65d7-e063-6294a90abaec1
240812ketoconazole 1 % Medicated ShampooSY49965e91-43c3-65d7-e063-6294a90abaec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-025-0176986002501300 mL in 1 BOTTLE (76986-025-01) 300 ml2026-01-30NoNoHistorical
76986-025-0276986002502450 mL in 1 BOTTLE (76986-025-02) 450 ml2026-01-30NoNoHistorical
76986-025-0376986002503750 mL in 1 BOTTLE (76986-025-03) 750 ml2026-01-30NoNoHistorical