FDA.reportPublic FDA data

IMIQUIMOD 5% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:37

Label at a glance#

ProductIMIQUIMOD 5% / NIACINAMIDE 4%
Active ingredientNIACINAMIDE, IMIQUIMOD
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934-1127-2 IMIQUIMOD USP 5% / NIACINAMIDE USP 4%. Gel 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5624e12d-8450-453b-aa8d-acacc0adf764Product name120210621
b519e8a5-29e1-d8cd-ace0-3915cc880d8fProduct name220150122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1127-22021-01-29C16284748780-1ba0f9c33-26d7-a910-e053-dadaa90a0b85IMIQUIMOD 5% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1127-2IMIQUIMOD 5% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1127IMIQUIMOD 5% / NIACINAMIDE 4% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190507_883d9905-d96a-a9a4-e053-2995a90ae6a8.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
72934-112772934-1127-2

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
IMIQUIMODP1QW714R7MACTIB

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
883d9905-d96b-a9a4-e053-2995a90ae6a8883d9905-d96a-a9a4-e053-2995a90ae6a82019-05-06Adverse reactionsExact identifier
spl id: 883d9905-d96b-a9a4-e053-2995a90ae6a8
spl set id: 883d9905-d96a-a9a4-e053-2995a90ae6a8

Reported adverse events (FAERS/openFDA)#

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