FDA.reportPublic FDA data

FLUOCINOLONE ACETONIDE 0.01/ 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 20:28:46

Label at a glance#

ProductFLUOCINOLONE ACETONIDE 0.01/ NIACINAMIDE 4
Active ingredientFLUOCINOLONE ACETONIDE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Diections for use

INSTRUCTIONS FOR USE SECTION

ff

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

cc

Active, inactive

COMPONENTS

cc

NDC 72934-2084-2 FLUOCINOLONE ACETONIDE 0.025% / NIACINAMIDE 4% Cream 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

xx

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUOCINOLONE ACETONIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2084-22021-01-29C16284748780-1ba0f9c33-4f8b-a910-e053-dadaa90a0b85FLUOCINOLONE ACETONIDE 0.025% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2084-2FLUOCINOLONE ACETONIDE 0.01/ NIACINAMIDE 430 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2084FLUOCINOLONE ACETONIDE 0.01/ NIACINAMIDE 4 CREAM [SINCERUS FLORIDA LLC]1Legacy NDC, 1 package rows20190517_88ca2e1e-c8ce-d58a-e053-2995a90a409f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2084-2GM - Gram72934-2084ef393728-4dc0-4ac3-a7ba-2de0800ba5f712020-03-10

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
72934-208472934-2084-2

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
FLUOCINOLONE ACETONIDE0CD5FD6S2MACTIB
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
88ca2e1e-c8cf-d58a-e053-2995a90a409f88ca2e1e-c8ce-d58a-e053-2995a90a409f2019-05-13Adverse reactionsExact identifier
spl id: 88ca2e1e-c8cf-d58a-e053-2995a90a409f
spl set id: 88ca2e1e-c8ce-d58a-e053-2995a90a409f

Reported adverse events (FAERS/openFDA)#

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