FDA.reportPublic FDA data

011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%

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 20:33:04

Label at a glance#

Product011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%
Active ingredientNIACINAMIDE, SPIRONOLACTONE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

aa

Sincerus Florida, LLC adverse reactions

ADVERSE REACTIONS SECTION

ADAD

Active, inactive

COMPONENTS

ss

NDC 72934-1205-2 011054 NIACINAMIDE 4% / SPIRONOLACTONE 5% gel 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ss

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1205-22022-01-28C16284748780-1d6a99b39-904d-a426-e053-dadaa90af4c2011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1205-2011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1205011054 NIACINAMIDE 4% / SPIRONOLACTONE 5% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20200703_a97c130d-1426-824b-e053-2995a90ad22f.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
72934-120572934-1205-2

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
SPIRONOLACTONE27O7W4T232ACTIB

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
a97c130d-1427-824b-e053-2995a90ad22fa97c130d-1426-824b-e053-2995a90ad22f2020-07-02Adverse reactionsExact identifier
spl id: a97c130d-1427-824b-e053-2995a90ad22f
spl set id: a97c130d-1426-824b-e053-2995a90ad22f

Reported adverse events (FAERS/openFDA)#

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