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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
47f0cbfb-b73b-4572-95d2-992c7382df3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50405-800-01	Hydroquinone 4%	28.35 g in 1 TUBE	CREAM	28.35		1
50405-800-01	Hydroquinone 4%	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50405-800	HYDROQUINONE 4% (HYDROQUINONE) CREAM [SOHM, INC.]	1	Current NDC, 2 package rows	20230606_47f0cbfb-b73b-4572-95d2-992c7382df3a.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroquinone 4%	HYDROQUINONE	SOHM, Inc.	47f0cbfb-b73b-4572-95d2-992c7382df3a	2023-06-05	Warnings, Adverse reactions	Exact identifier ndc (product): 50405-800

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XV74C1N1AE	HYDROQUINONE	123-31-9	HYDROQUINONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197795	hydroquinone 4 % Topical Cream	PSN	47f0cbfb-b73b-4572-95d2-992c7382df3a	1
197795	hydroquinone 40 MG/ML Topical Cream	SCD	47f0cbfb-b73b-4572-95d2-992c7382df3a	1
197795	hydroquinone 4 % Topical Cream	SY	47f0cbfb-b73b-4572-95d2-992c7382df3a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50405-800-01	50405080001	1 TUBE in 1 CARTON (50405-800-01) / 28.35 g in 1 TUBE	1 tube	2023-06-05	No	No	Current