FDA.reportPublic FDA data

HYDROQUINONE 8%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:28

Label at a glance#

ProductHYDROQUINONE 8%
Active ingredientHYDROQUINONE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dd

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

xx

Active, inactive

COMPONENTS

ss

NDC 72934-6121-2 Hydroquinone USP 8%. Emulsion 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

xx

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-6121-22021-01-29C16284748780-1ba0f9c33-11b2-a910-e053-dadaa90a0b85HYDROQUINONE 8%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-6121-2HYDROQUINONE 8%30 g in 1 BOTTLE, PUMPEMULSION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-6121HYDROQUINONE 8% EMULSION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_874c1900-82ec-4082-e053-2995a90aff22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-6121-2GM - Gram72934-612155ffdcf4-0381-45cd-8253-44312328077c12020-03-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-612172934-6121-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB

Source Document#

Source XML · Source PDF

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
874c1900-82ed-4082-e053-2995a90aff22874c1900-82ec-4082-e053-2995a90aff222019-04-24Adverse reactionsExact identifier
spl id: 874c1900-82ed-4082-e053-2995a90aff22
spl set id: 874c1900-82ec-4082-e053-2995a90aff22

Reported adverse events (FAERS/openFDA)#

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