FDA.reportPublic FDA data

IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%

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#

ProductIMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%
Active ingredientIMIQUIMOD, LEVOCETIRIZINE DIHYDROCHLORIDE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

zz

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

xx

Active, Inactive

COMPONENTS

dd

NDC 72934-1125-2 IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%, Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zz

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IMIQUIMOD Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5624e12d-8450-453b-aa8d-acacc0adf764Product name120210621
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702
b519e8a5-29e1-d8cd-ace0-3915cc880d8fProduct name220150122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1125-22021-01-29C16284748780-1ba0f9c33-1188-a910-e053-dadaa90a0b85IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1125-2IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1125IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_8738d91c-e66f-0a37-e053-2991aa0a663e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-1125-2GM - Gram72934-11256e2cf969-c0a4-4c49-95ca-ae7724a7609912020-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-112572934-1125-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
IMIQUIMODP1QW714R7MACTIB
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB
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
8738d91c-e670-0a37-e053-2991aa0a663e8738d91c-e66f-0a37-e053-2991aa0a663e2019-04-23Adverse reactionsExact identifier
spl id: 8738d91c-e670-0a37-e053-2991aa0a663e
spl set id: 8738d91c-e66f-0a37-e053-2991aa0a663e

Reported adverse events (FAERS/openFDA)#

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