FDA.reportPublic FDA data

011312 NIACINAMIDE 4% / TAZAROTENE 0.05%

Manufacturer
Sincerus Florida, LLC
Effective date
2020-07-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:33:02

Label at a glance#

Product011312 NIACINAMIDE 4% / TAZAROTENE 0.05%
Active ingredientTAZAROTENE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ee

Sincerus Florida, LLC adverse reactions

ADVERSE REACTIONS SECTION

ss

Active, Inactive

COMPONENTS

aa

NDC 72934-2208-2 011312 NIACINAMIDE 4% / TAZAROTENE 0.05% cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2208-22022-01-28C16284748780-1d6a99b39-7559-a426-e053-dadaa90af4c2011312 NIACINAMIDE 4% / TAZAROTENE 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2208-2011312 NIACINAMIDE 4% / TAZAROTENE 0.05%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2208011312 NIACINAMIDE 4% / TAZAROTENE 0.05% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20200703_a97a190f-1f98-1fb0-e053-2a95a90a6850.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
72934-220872934-2208-2

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
TAZAROTENE81BDR9Y8PSACTIB
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
a97a190f-1f99-1fb0-e053-2a95a90a6850a97a190f-1f98-1fb0-e053-2a95a90a68502020-07-02Adverse reactionsExact identifier
spl id: a97a190f-1f99-1fb0-e053-2a95a90a6850
spl set id: a97a190f-1f98-1fb0-e053-2a95a90a6850

Reported adverse events (FAERS/openFDA)#

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