FDA.reportPublic FDA data

Hydroquinone 4%

Product NDC
72162-2422
11-digit product format
721622422
Labeler code
72162
Product ID
72162-2422_e5a43bea-0366-423e-90ef-90438278a712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-08-17
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroquinone 4%
Listing expiration
2027-12-31

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
ba2b7504-17bb-4b9e-8db1-937f83d75a03Available 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
72162-2422-2Hydroquinone 4%1 in 1 CARTONCREAM1101
72162-2422-2Hydroquinone 4%28.4 g in 1 TUBECREAM28.4101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2422-2GM - Gram72162-2422bfdb9425-bfc4-4d94-b028-571ccf5cb53312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2422HYDROQUINONE 4% (HYDROQUINONE) CREAM [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20241113_ba2b7504-17bb-4b9e-8db1-937f83d75a03.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
Hydroquinone 4%HYDROQUINONEBryant Ranch Prepackba2b7504-17bb-4b9e-8db1-937f83d75a032026-03-17Warnings, Adverse reactionsExact identifier
ndc (product): 72162-2422

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSNba2b7504-17bb-4b9e-8db1-937f83d75a03101
197795hydroquinone 40 MG/ML Topical CreamSCDba2b7504-17bb-4b9e-8db1-937f83d75a03101
197795hydroquinone 4 % Topical CreamSYba2b7504-17bb-4b9e-8db1-937f83d75a03101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2422-2721622422021 TUBE in 1 CARTON (72162-2422-2) / 28.4 g in 1 TUBE1 tube2022-08-17NoNoCurrent