FDA.reportPublic FDA data

BENZOYL PEROXIDE 8% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida | Sincerus Florida, LLC
Effective date
2019-05-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:41

Label at a glance#

ProductBENZOYL PEROXIDE 8% / NIACINAMIDE 4%
Active ingredientBENZOYL PEROXIDE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

dsds

Active, inactive

COMPONENTS

dd

NDC 72934-8022-6 BENZOYL PEROXIDE USP 8% / NIACINAMIDE USP 4%. Suspension 120gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-8022-62021-01-29C16284748780-1ba0f9c33-4ef8-a910-e053-dadaa90a0b85BENZOYL PEROXIDE 8% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-8022-6BENZOYL PEROXIDE 8% / NIACINAMIDE 4%120 g in 1 BOTTLE, PLASTICSUSPENSION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-8022BENZOYL PEROXIDE 8% / NIACINAMIDE 4% SUSPENSION [SINCERUS FLORIDA]1Legacy NDC, 1 package rows20190511_888b2203-46a3-d599-e053-2995a90a7de1.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
72934-802272934-8022-6

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
BENZOYL PEROXIDEW9WZN9A0GMACTIB
NIACINAMIDE25X51I8RD4ACTIB

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
888b2203-46a4-d599-e053-2995a90a7de1888b2203-46a3-d599-e053-2995a90a7de12019-05-10Adverse reactionsExact identifier
spl id: 888b2203-46a4-d599-e053-2995a90a7de1
spl set id: 888b2203-46a3-d599-e053-2995a90a7de1

Reported adverse events (FAERS/openFDA)#

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