MedPath

Hydroquinone 4%

Hydroquinone USP, 4%

Approved
Approval ID

47f0cbfb-b73b-4572-95d2-992c7382df3a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 5, 2023

Manufacturers
FDA

SOHM, Inc.

DUNS: 009303848

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydroquinone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50405-800
Product Classification
G
Generic Name
Hydroquinone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (11)

HydroquinoneActive
Quantity: 40 mg in 1 g
Code: XV74C1N1AE
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)Inactive
Code: 1DXE3F3OZX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
Sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Hydroquinone 4% - FDA Drug Approval Details