FDA.reportPublic FDA data

ADAPALENE 0.3% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:40

Label at a glance#

ProductADAPALENE 0.3% / NIACINAMIDE 4%
Active ingredientADAPALENE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ss

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

asas

Active, inactive

COMPONENTS

dd

NDC 72934-1006-2 ADAPALENE USP 0.3% / NIACINAMIDE USP 4%. Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ssss

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1006-22021-01-29C16284748780-1ba0f9c33-118b-a910-e053-dadaa90a0b85ADAPALENE 0.3% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1006-2ADAPALENE 0.3% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1006ADAPALENE 0.3% / NIACINAMIDE 4% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190510_88798d2c-ae6a-2a2d-e053-2995a90a7f9f.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-100672934-1006-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADAPALENE1L4806J2QFACTIB
NIACINAMIDE25X51I8RD4ACTIB

Source Document#

Source XML

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
88798d2c-ae6b-2a2d-e053-2995a90a7f9f88798d2c-ae6a-2a2d-e053-2995a90a7f9f2019-05-09Adverse reactionsExact identifier
spl id: 88798d2c-ae6b-2a2d-e053-2995a90a7f9f
spl set id: 88798d2c-ae6a-2a2d-e053-2995a90a7f9f

Reported adverse events (FAERS/openFDA)#

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