FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
42192-149
11-digit product format
421920149
Labeler code
42192
Product ID
42192-149_db2b5db3-6b73-4292-874e-d1893b647429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide and Sulfur
Dosage form
CREAM
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-08-14
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, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70, 4NRT660KJQ
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
42192-149-02SODIUM SULFACETAMIDE, SULFUR57 g in 1 TUBECREAM574

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-149-02GM - Gram42192-1499e2b8d9e-8f38-4cd8-85c1-0f1c39b2392212014-09-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-149SODIUM SULFACETAMIDE, SULFUR (SODIUM SULFACETAMIDE AND SULFUR) CREAM [ACELLA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240113_99705c54-b7af-423d-8f20-881e8fea236f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSN99705c54-b7af-423d-8f20-881e8fea236f4
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCD99705c54-b7af-423d-8f20-881e8fea236f4
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSY99705c54-b7af-423d-8f20-881e8fea236f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-149-024219201490257 g in 1 TUBE (42192-149-02) 57 g2014-08-140000-00-00NoNoCurrent