FDA.reportPublic FDA data

ECONAZOLE NITRATE 1% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:52

Label at a glance#

ProductECONAZOLE NITRATE 1% / NIACINAMIDE 4%
Active ingredientECONAZOLE NITRATE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 2073-2 ECONAZOLE NITRATE USP 1% / NIACINAMIDE USP 4%. Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2073-22021-01-29C16284748780-1ba0f9c33-304e-a910-e053-dadaa90a0b85ECONAZOLE NITRATE 1% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2073-2ECONAZOLE NITRATE 1% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2073ECONAZOLE NITRATE 1% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190521_895613a0-68c6-2f38-e053-2995a90af107.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2073-2GM - Gram72934-2073fefc386a-64c0-400b-8a35-36a252c2bc0712020-03-10

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-207372934-2073-2

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
ECONAZOLE NITRATEH438WYN10EACTIB
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
895613a0-68c7-2f38-e053-2995a90af107895613a0-68c6-2f38-e053-2995a90af1072019-05-20Adverse reactionsExact identifier
spl id: 895613a0-68c7-2f38-e053-2995a90af107
spl set id: 895613a0-68c6-2f38-e053-2995a90af107

Reported adverse events (FAERS/openFDA)#

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