FDA.reportPublic FDA data

NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15%

Manufacturer
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#

ProductNIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15%
Active ingredientNIACINAMIDE, SULFACETAMIDE SODIUM
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ff

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

ss

Active, Inactive

COMPONENTS

ss

NDC 72934-3156-2 NIACINAMIDE USP 4% / SODIUM SULFACETAMIDE MONOHYDRATE USP 15%. Lotion 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-3156-22021-01-29C16284748780-1ba0f9c33-1194-a910-e053-dadaa90a0b85NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-3156-2NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15%30 g in 1 BOTTLE, PUMPLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-3156NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15% LOTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190511_888ac23c-6a1a-8253-e053-2a95a90a2ae8.zip

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
72934-315672934-3156-2

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
NIACINAMIDE25X51I8RD4ACTIB
SULFACETAMIDE SODIUM4NRT660KJQACTIB

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
888ac23c-6a1b-8253-e053-2a95a90a2ae8888ac23c-6a1a-8253-e053-2a95a90a2ae82019-05-10Adverse reactionsExact identifier
spl id: 888ac23c-6a1b-8253-e053-2a95a90a2ae8
spl set id: 888ac23c-6a1a-8253-e053-2a95a90a2ae8

Reported adverse events (FAERS/openFDA)#

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