FDA.reportPublic FDA data

KETOCONAZOLE 2% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida LLC
Effective date
2019-05-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:42

Label at a glance#

ProductKETOCONAZOLE 2% / NIACINAMIDE 4%
Active ingredientKETOCONAZOLE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

kk

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

pp

Active, inactive

COMPONENTS

ff

NDC 72934-2132-2 KETOCONAZOLE 2% / NIACINAMIDE 4% Cream 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ss

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2132-22021-01-29C16284748780-1ba0f9c33-11b5-a910-e053-dadaa90a0b85KETOCONAZOLE 2% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2132-2KETOCONAZOLE 2% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2132KETOCONAZOLE 2% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA LLC]1Legacy NDC, 1 package rows20190514_88c97b7c-b916-bd3a-e053-2995a90ab422.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
72934-213272934-2132-2

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
KETOCONAZOLER9400W927IACTIB
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
88c97b7c-b917-bd3a-e053-2995a90ab42288c97b7c-b916-bd3a-e053-2995a90ab4222019-05-13Adverse reactionsExact identifier
spl id: 88c97b7c-b917-bd3a-e053-2995a90ab422
spl set id: 88c97b7c-b916-bd3a-e053-2995a90ab422

Reported adverse events (FAERS/openFDA)#

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