FDA.reportPublic FDA data

Sodium Sulfacetamide 8% and Sulfur 4% Cleanser

Product NDC
72162-2247
11-digit product format
721622247
Labeler code
72162
Product ID
72162-2247_aca6c078-9c4a-4b71-bf22-41fda60da005
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-02-01
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
80; 40 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide 8% and Sulfur 4% Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM80 mg/mL
SULFUR40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1010234

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
72162-2247-2Sodium Sulfacetamide 8% and Sulfur 4% Cleanser473 mL in 1 BOTTLE, PLASTICLIQUID473101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2247-2ML - Milliliter72162-22473e3a5758-2d11-4b82-9ead-b7beef48da0f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2247SODIUM SULFACETAMIDE 8% AND SULFUR 4% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240131_fb0c9508-0ff1-46eb-8df0-4bfd2c123187.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYfb0c9508-0ff1-46eb-8df0-4bfd2c123187101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2247-272162224702473 mL in 1 BOTTLE, PLASTIC (72162-2247-2) 473 ml2026-03-19NoNoHistorical