Sodium Sulfacetamide 10 Sulfur 2 cream

Product NDC
42192-150
11-digit product format
421920150
Labeler code
42192
Product ID
42192-150_04ebb5f9-8352-433f-9b8a-5b7e7ead6a18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Sulfur
Dosage form
CREAM
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-08-21
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 20 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 Sulfur 2 cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1000731

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
42192-150-02Sodium Sulfacetamide 10 Sulfur 2 cream57 g in 1 BOTTLECREAM575

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-150-02GM - Gram42192-15026c346ae-d636-46cf-af2c-f52467e1187212014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-150SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM (SULFACETAMIDE SODIUM AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20250515_a57b734d-5d6d-4cd7-8003-9174cc785e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000731sulfacetamide sodium 10 % / sulfur 2 % Topical CreamPSNa57b734d-5d6d-4cd7-8003-9174cc785e415
1000731sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Topical CreamSCDa57b734d-5d6d-4cd7-8003-9174cc785e415
1000731sulfacetamide sodium 10 % / sulfur 2 % Topical CreamSYa57b734d-5d6d-4cd7-8003-9174cc785e415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-150-024219201500257 g in 1 BOTTLE (42192-150-02) 57 g2014-08-210000-00-00NoNoCurrent