011503 DAPSONE 6% / NIACINAMIDE 2% / 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 20:33:02

Label at a glance#

Product011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%

Active ingredientNIACINAMIDE, SPIRONOLACTONE, DAPSONE

Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

Sincerus Florida, LLC adverse reactions

ADVERSE REACTIONS SECTION

Active, Inactive

COMPONENTS

NDC 72934-1211-2 011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5% gel 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DAPSONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
SPIRONOLACTONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ae3f83f-9ccb-db71-5718-0b1e959868df	Product name	5	20260113
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
5ae2790a-f798-4a69-8811-64a4723c389a	Product name	5	20250325
b8929bfc-0002-d39a-046d-72ddf714efbe	Product name	6	20190618
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72934-1211-2	2022-01-28	C162847	48780-1	d6a99b39-dc96-a426-e053-dadaa90af4c2	011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72934-1211-2	011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%	30 g in 1 BOTTLE, PUMP	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72934-1211	011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5% GEL [SINCERUS FLORIDA, LLC]	1	Legacy NDC, 1 package rows	20200703_a97a5200-06de-1fad-e053-2a95a90a996d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
NIACINAMIDE
SPIRONOLACTONE
DAPSONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72934-1211	72934-1211-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NIACINAMIDE	25X51I8RD4	ACTIB
SPIRONOLACTONE	27O7W4T232	ACTIB
DAPSONE	8W5C518302	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a97a5200-06df-1fad-e053-2a95a90a996d			a97a5200-06de-1fad-e053-2a95a90a996d	2020-07-02	Adverse reactions	Exact identifier spl id: a97a5200-06df-1fad-e053-2a95a90a996d spl set id: a97a5200-06de-1fad-e053-2a95a90a996d

Reported adverse events (FAERS/openFDA)#

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