FDA.reportPublic FDA data

ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2020-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:51

Label at a glance#

ProductADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%
Active ingredientNIACINAMIDE, ADAPALENE, BENZOYL PEROXIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions or use

INSTRUCTIONS FOR USE SECTION

hh

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

gg

Active, inactive

COMPONENTS

123123

NDC 72934-1005-2 ADAPALENE 0.3 / BENZOYL PEROXIDE 2.5 / NIACINAMIDE 4 gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
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
72934-1005-22022-01-28C16284748780-1d6a99b39-a7ff-a426-e053-dadaa90af4c2ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1005-2ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1005ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4% GEL [SINCERUS FLORIDA, LLC]2Legacy NDC, 1 package rows20200604_87391cb8-def0-a107-e053-2991aa0a561b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-1005-2GM - Gram72934-10050c6e6af6-ba5a-4d2c-b9bb-0aed75daff4212020-02-13

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-100572934-1005-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4ACTIB
ADAPALENE1L4806J2QFACTIB
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
a731513c-c772-31e3-e053-2a95a90aba8687391cb8-def0-a107-e053-2991aa0a561b2020-06-03Adverse reactionsExact identifier
spl id: a731513c-c772-31e3-e053-2a95a90aba86
spl set id: 87391cb8-def0-a107-e053-2991aa0a561b

Reported adverse events (FAERS/openFDA)#

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