hydroquinone

Product NDC
10135-724
11-digit product format
101350724
Labeler code
10135
Product ID
10135-724_438085c1-0d95-b6b3-e063-6394a90ada2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Marlex Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-03-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XV74C1N1AEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197795Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be22c3e0-8760-1568-e053-2995a90a112aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-724-99hydroquinone1 in 1 CARTONCREAM15
10135-724-99hydroquinone28.35 g in 1 TUBECREAM28.355

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-724-99GM - Gram10135-724547b0f78-7bc6-4596-aa3d-a754717862ad12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-724HYDROQUINONE CREAM [MARLEX PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20241009_be22c3e0-8760-1568-e053-2995a90a112a.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydroquinoneHYDROQUINONEMarlex Pharmaceuticals, Inc.be22c3e0-8760-1568-e053-2995a90a112a2025-11-13Warnings, Adverse reactionsExact identifier
ndc (product): 10135-724

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSNbe22c3e0-8760-1568-e053-2995a90a112a5
197795hydroquinone 40 MG/ML Topical CreamSCDbe22c3e0-8760-1568-e053-2995a90a112a5
197795hydroquinone 4 % Topical CreamSYbe22c3e0-8760-1568-e053-2995a90a112a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-724-99101350724991 TUBE in 1 CARTON (10135-724-99) / 28.35 g in 1 TUBE1 tube2021-03-010000-00-00NoNoCurrent