FDA.reportPublic FDA data

CLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:27

Label at a glance#

ProductCLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4%
Active ingredientCLOBETASOL PROPIONATE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ss

Sincerus Florida, LLC adverse reactions

ADVERSE REACTIONS SECTION

zz

Active, inactive

COMPONENTS

dd

NDC 72934-4059-5 CLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4%% solution 60gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zz

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-4059-52021-01-29C16284748780-1ba0f9c33-4458-a910-e053-dadaa90a0b85CLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4059-5CLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4%60 g in 1 CYLINDERSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4059CLOBETASOL PROPIONATE 0.05% / NIACINAMIDE 4% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_874b5c58-9876-5fc0-e053-2a95a90ad7b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-4059-5GM - Gram72934-40590fcfaf13-77e7-422e-a46f-d3461680757112020-03-10

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
72934-405972934-4059-5

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
CLOBETASOL PROPIONATE779619577MACTIB
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
874b5c58-9877-5fc0-e053-2a95a90ad7b8874b5c58-9876-5fc0-e053-2a95a90ad7b82019-04-24Adverse reactionsExact identifier
spl id: 874b5c58-9877-5fc0-e053-2a95a90ad7b8
spl set id: 874b5c58-9876-5fc0-e053-2a95a90ad7b8

Reported adverse events (FAERS/openFDA)#

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