FDA.reportPublic FDA data

FLUTICASONE PROPIONATE 0.05% / 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#

ProductFLUTICASONE PROPIONATE 0.05% / NIACINAMIDE 4%
Active ingredientFLUTICASONE PROPIONATE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ww

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

ss

Active, inactives

COMPONENTS

ee

NDC 72934- 2087-2 FLUTICASONE PROPIONATE USP 0.05% / NIACINAMIDE USP 4%. Cream 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aa

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2087-22021-01-29C16284748780-1ba0f9c33-58c8-a910-e053-dadaa90a0b85FLUTICASONE PROPIONATE 0.05% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2087-2FLUTICASONE PROPIONATE 0.05% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2087FLUTICASONE PROPIONATE 0.05% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190514_88c597c2-0db1-a1d2-e053-2995a90a3411.zip

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
72934-208772934-2087-2

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
FLUTICASONE PROPIONATEO2GMZ0LF5WACTIB
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
88c597c2-0db2-a1d2-e053-2995a90a341188c597c2-0db1-a1d2-e053-2995a90a34112019-05-13Adverse reactionsExact identifier
spl id: 88c597c2-0db2-a1d2-e053-2995a90a3411
spl set id: 88c597c2-0db1-a1d2-e053-2995a90a3411

Reported adverse events (FAERS/openFDA)#

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