FDA.reportPublic FDA data

Sodium Sulfacetamide and Sulfur

Product NDC
42192-133
11-digit product format
421920133
Labeler code
42192
Product ID
42192-133_888fce7d-dc47-4d1b-9c39-9dfcaa051607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide and Sulfur
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide and Sulfur
Listing expiration
2026-12-31

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
42192-133-16Sodium Sulfacetamide and Sulfur473 mL in 1 BOTTLESOLUTION4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-133-16ML - Milliliter42192-133651383c9-6f49-4764-b633-98d905e8f35a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sulfacetamide SodiumACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SulfurACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SulfacetamideACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SulfurACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEINACTIVE INGREDIENT5M1101WGSYSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-133SODIUM SULFACETAMIDE AND SULFUR SOLUTION [ACELLA PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20240112_c3ff4716-6009-4e29-9da9-ea740726cc3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNc3ff4716-6009-4e29-9da9-ea740726cc3c5
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDc3ff4716-6009-4e29-9da9-ea740726cc3c5
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYc3ff4716-6009-4e29-9da9-ea740726cc3c5
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYc3ff4716-6009-4e29-9da9-ea740726cc3c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-133-1642192013316473 mL in 1 BOTTLE (42192-133-16) 473 ml2011-05-130000-00-00NoNoCurrent