FDA.reportPublic FDA data

SALICYLIC ACID 2% / SODIUM SULFACETAMIDE MONOHYDRATE 8%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:47

Label at a glance#

ProductSALICYLIC ACID 2% / SODIUM SULFACETAMIDE MONOHYDRATE 8%
Active ingredientSULFACETAMIDE SODIUM, SALICYLIC ACID
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dada

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

aadsds

Active, inactive

COMPONENTS

dwsdws

NDC 72934- 8171-6 SALICYLIC ACID USP 2% / SODIUM SULFACETAMIDE MONOHYDRATE USP 8%.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sdsd

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-8171-62021-01-29C16284748780-1ba0f9c33-4506-a910-e053-dadaa90a0b85SALICYLIC ACID 2% / SODIUM SULFACETAMIDE MONOHYDRATE 8%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-8171-6SALICYLIC ACID 2% / SODIUM SULFACETAMIDE MONOHYDRATE 8%120 g in 1 CYLINDERSUSPENSION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-8171SALICYLIC ACID 2% / SODIUM SULFACETAMIDE MONOHYDRATE 8% SUSPENSION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190517_89067701-e5b2-1c3d-e053-2a95a90a4e11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-8171-6GM - Gram72934-8171c2cf3c88-287c-4d5a-9d3e-248dcee43e0512020-03-10

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
72934-817172934-8171-6

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
SULFACETAMIDE SODIUM4NRT660KJQACTIB
SALICYLIC ACIDO414PZ4LPZACTIB

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
89067701-e5b3-1c3d-e053-2a95a90a4e1189067701-e5b2-1c3d-e053-2a95a90a4e112019-05-16Adverse reactionsExact identifier
spl id: 89067701-e5b3-1c3d-e053-2a95a90a4e11
spl set id: 89067701-e5b2-1c3d-e053-2a95a90a4e11

Reported adverse events (FAERS/openFDA)#

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