Hydroquinone 4%

Product NDC
50405-800
11-digit product format
504050800
Labeler code
50405
Product ID
50405-800_d639c140-a4bf-41cd-8ca3-45ee38a2c0b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
SOHM, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-05
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
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50405-800-01Hydroquinone 4%28.35 g in 1 TUBECREAM28.351
50405-800-01Hydroquinone 4%1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-800HYDROQUINONE 4% (HYDROQUINONE) CREAM [SOHM, INC.]1Current NDC, 2 package rows20230606_47f0cbfb-b73b-4572-95d2-992c7382df3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSN47f0cbfb-b73b-4572-95d2-992c7382df3a1
197795hydroquinone 40 MG/ML Topical CreamSCD47f0cbfb-b73b-4572-95d2-992c7382df3a1
197795hydroquinone 4 % Topical CreamSY47f0cbfb-b73b-4572-95d2-992c7382df3a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50405-800-01504050800011 TUBE in 1 CARTON (50405-800-01) / 28.35 g in 1 TUBE1 tube2023-06-05NoNoHistorical