Sodium Sulfacetamide and Sulfur

Product NDC
42192-133
Requested package NDC
42192-133-16
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
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010234Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3ff4716-6009-4e29-9da9-ea740726cc3cAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfacetamide and SulfurSODIUM SULFACETAMIDE AND SULFURAcella Pharmaceuticals, LLCc3ff4716-6009-4e29-9da9-ea740726cc3c2026-07-14Warnings, Adverse reactionsExact identifier
ndc (package): 42192-133-16
ndc (product): 42192-133
ndc11 (package): 42192013316

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