FDA.reportPublic FDA data

AZELAIC ACID 15% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:26

Label at a glance#

ProductAZELAIC ACID 15% / NIACINAMIDE 4%
Active ingredientAZELAIC ACID, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Active, inactive

COMPONENTS

ff

Directions for use

INSTRUCTIONS FOR USE SECTION

ss

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

cc

NDC 72934-2008-2 AZELAIC ACID 15%, NIACINAMIDE USP 4%, CREAM 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AZELAIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2008-22021-01-29C16284748780-1ba0f9c33-44a3-a910-e053-dadaa90a0b85AZELAIC ACID 15% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2008-2AZELAIC ACID 15% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2008AZELAIC ACID 15% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_87391cb8-def7-a107-e053-2991aa0a561b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2008-2GM - Gram72934-200862216be2-50a8-409c-85fa-619cf2d5454812020-03-10

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
72934-200872934-2008-2

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
AZELAIC ACIDF2VW3D43YTACTIB
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
87391cb8-def8-a107-e053-2991aa0a561b87391cb8-def7-a107-e053-2991aa0a561b2019-04-23Adverse reactionsExact identifier
spl id: 87391cb8-def8-a107-e053-2991aa0a561b
spl set id: 87391cb8-def7-a107-e053-2991aa0a561b

Reported adverse events (FAERS/openFDA)#

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