FDA.reportPublic FDA data

DAPSONE 8.5% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:25

Label at a glance#

ProductDAPSONE 8.5% / NIACINAMIDE 4%
Active ingredientDAPSONE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ff

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

ss

Active, inactive

COMPONENTS

dd

NDC 72934-1066-2 DAPSONE 8.5 / NIACINAMIDE 4 Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae3f83f-9ccb-db71-5718-0b1e959868dfProduct name520260113
5ae2790a-f798-4a69-8811-64a4723c389aProduct name520250325
b8929bfc-0002-d39a-046d-72ddf714efbeProduct name620190618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1066-22021-01-29C16284748780-1ba0f9c33-3b3a-a910-e053-dadaa90a0b85DAPSONE 8.5% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1066-2DAPSONE 8.5% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1066DAPSONE 8.5% / NIACINAMIDE 4% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_8738b667-e55b-5543-e053-2991aa0a5530.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-1066-2GM - Gram72934-10667bb7b23d-2a39-434a-b276-ff74cd476f3212020-02-13

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
72934-106672934-1066-2

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
DAPSONE8W5C518302ACTIB
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
8738b667-e55c-5543-e053-2991aa0a55308738b667-e55b-5543-e053-2991aa0a55302019-04-23Adverse reactionsExact identifier
spl id: 8738b667-e55c-5543-e053-2991aa0a5530
spl set id: 8738b667-e55b-5543-e053-2991aa0a5530

Reported adverse events (FAERS/openFDA)#

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