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 Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70

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#

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

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