FDA.reportPublic FDA data

NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 10%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:54

Label at a glance#

ProductNIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 10%
Active ingredientSULFACETAMIDE SODIUM, 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

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Active, inactive

COMPONENTS

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NDC 72934- 2156-2 NIACINAMIDE USP 4% / SODIUM SULFACETAMIDE MONOHYDRATE USP 10%. Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
72934-2156-22021-01-29C16284748780-1ba0f9c33-26a4-a910-e053-dadaa90a0b85NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2156-2NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 10%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2156NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 10% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190523_897f7f12-9515-e355-e053-2a95a90a2e9d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2156-2GM - Gram72934-2156a4b843c0-50c8-4e43-8aef-1ecf17bcf99712020-03-10

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
72934-215672934-2156-2

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
SULFACETAMIDE SODIUM4NRT660KJQACTIB
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
897f7f12-9516-e355-e053-2a95a90a2e9d897f7f12-9515-e355-e053-2a95a90a2e9d2019-05-22Adverse reactionsExact identifier
spl id: 897f7f12-9516-e355-e053-2a95a90a2e9d
spl set id: 897f7f12-9515-e355-e053-2a95a90a2e9d

Reported adverse events (FAERS/openFDA)#

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