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 Identifiers#

Field, Values table
FieldValues
UniiXV74C1N1AE
Rxcui197795

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

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