FDA.reportPublic FDA data

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream

Product NDC
72162-2246
11-digit product format
721622246
Labeler code
72162
Product ID
72162-2246_19d9af58-ede2-4536-879e-a934ae957c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-05-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005834

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
72162-2246-2SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream28 g in 1 BOTTLE, PLASTICCREAM28101
72162-2246-4SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream57 g in 1 BOTTLE, PLASTICCREAM57101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2246-2GM - Gram72162-2246bb10faae-7d87-4a26-b259-c57aa1495a3512024-03-12
72162-2246-4GM - Gram72162-224692923320-ec6e-4eee-b36d-caa22b1c1c4512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2246SODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAM CREAM [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240131_4ebfcaae-a375-45aa-a7f9-2b622f564f02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSN4ebfcaae-a375-45aa-a7f9-2b622f564f02101
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCD4ebfcaae-a375-45aa-a7f9-2b622f564f02101
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSY4ebfcaae-a375-45aa-a7f9-2b622f564f02101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2246-27216222460228 g in 1 BOTTLE, PLASTIC (72162-2246-2) 28 g2022-05-15NoNoHistorical
72162-2246-47216222460457 g in 1 BOTTLE, PLASTIC (72162-2246-4) 57 g2022-05-15NoNoHistorical