FDA.reportPublic FDA data

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser

Product NDC
71399-0486
11-digit product format
713990486
Labeler code
71399
Product ID
71399-0486_1d24578a-fa8b-479f-b3c0-8819c7375256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Akron Pharma Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
9.8; 4.8 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM9.8 mg/g
SULFUR4.8 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f6809f0-10f9-4d1b-a8f6-6a6745b04dbaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
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
71399-0486-12023-03-26C16284748780-1f386c64a-183b-0266-e053-dadaa90a7c1aSodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser
71399-0486-12023-01-30C16284748780-1f386c64a-183b-0266-e053-dadaa90a7c1aSodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0486-1Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser285 g in 1 BOTTLE, PLASTICLIQUID2853

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0486-1GM - Gram71399-04867282eb16-2df8-48de-a3ea-69cb18b3a11512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0486SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [AKRON PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20240926_8f6809f0-10f9-4d1b-a8f6-6a6745b04dba.zip

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
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.8f6809f0-10f9-4d1b-a8f6-6a6745b04dba2024-09-24Warnings, Adverse reactionsExact identifier
ndc (product): 71399-0486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0486-171399048601285 g in 1 BOTTLE, PLASTIC (71399-0486-1) 285 g2024-09-130000-00-00NoNoCurrent