FDA.reportPublic FDA data

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser

Product NDC
42192-156
11-digit product format
421920156
Labeler code
42192
Product ID
42192-156_95f45cf0-cdf3-4755-85b4-b2de8bf5735b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-12-12
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 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 SODIUM98 mg/g
SULFUR48 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1494169

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
42192-156-10Sodium 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
42192-156-10GM - Gram42192-15604f8043a-f130-42c9-b092-93a7578d74af12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-156SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240116_b21b36da-5475-4b01-8afd-1598f29c9b5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapPSNb21b36da-5475-4b01-8afd-1598f29c9b5d3
1494169sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Medicated Liquid SoapSCDb21b36da-5475-4b01-8afd-1598f29c9b5d3
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapSYb21b36da-5475-4b01-8afd-1598f29c9b5d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-156-1042192015610285 g in 1 BOTTLE, PLASTIC (42192-156-10) 285 g2016-12-120000-00-00NoNoCurrent