Home NDC 42192-151 HYDROQUINONE 4%
Product NDC 42192-151
11-digit product format 421920151
Labeler code 42192
Product ID 42192-151_f57301e6-8034-4bad-9e6f-8ced5571c494
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroquinone
Dosage form CREAM
Route TOPICAL
Labeler Acella Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-09-10
Substance HYDROQUINONE
Active strength 40 mg/g
Pharmacologic classes Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base HYDROQUINONE 4%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROQUINONE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XV74C1N1AE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197795 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 42192-151-01 HYDROQUINONE 4% 28.35 g in 1 TUBE CREAM 28.35 4 42192-151-01 HYDROQUINONE 4% 1 in 1 CARTON CREAM 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROQUINONE ACTIVE INGREDIENT XV74C1N1AE HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 HYDROQUINONE ACTIVE MOIETY XV74C1N1AE HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 C13-14 ISOPARAFFIN INACTIVE INGREDIENT E4F12ROE70 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 CAPRYLOYL GLYCINE INACTIVE INGREDIENT 8TY5YO42NJ HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 GLYCOLIC ACID INACTIVE INGREDIENT 0WT12SX38S HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 KOJIC ACID INACTIVE INGREDIENT 6K23F1TT52 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 LAURETH-7 INACTIVE INGREDIENT Z95S6G8201 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) INACTIVE INGREDIENT RHA9LWJ494 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42192-151 HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240116_595dfc50-ee6f-41b5-ab5b-4c293aee342b.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 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 Marketing end Sample Exclude flag Status 42192-151-01 42192015101 1 TUBE in 1 CARTON (42192-151-01) / 28.35 g in 1 TUBE 1 tube 2014-09-10 0000-00-00 No No Current