FDA.reportPublic FDA data

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

Product NDC
71399-0488
11-digit product format
713990488
Labeler code
71399
Product ID
71399-0488_6e9e8006-a0bc-4aaf-bc66-2cd7ed06983b
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
100; 50 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 10% and Sulfur 5% Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui999613

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0488-6Sodium Sulfacetamide 10% and Sulfur 5% Cleanser170.3 g in 1 BOTTLE, PLASTICLIQUID170.34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0488-6GM - Gram71399-04887b5fec94-0306-4813-b53c-8f238e7b908712021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0488SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20240926_7746061b-94e6-4e33-8a40-cf1ef16a198b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN7746061b-94e6-4e33-8a40-cf1ef16a198b4
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD7746061b-94e6-4e33-8a40-cf1ef16a198b4
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY7746061b-94e6-4e33-8a40-cf1ef16a198b4
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY7746061b-94e6-4e33-8a40-cf1ef16a198b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0488-671399048806170.3 g in 1 BOTTLE, PLASTIC (71399-0488-6) 170.3 g2024-09-130000-00-00NoNoCurrent