FDA.reportPublic FDA data

Sodium Sulfacetamide 10 Sulfur 5 Cleanser

Product NDC
42192-136
11-digit product format
421920136
Labeler code
42192
Product ID
42192-136_679caef9-ee89-4c41-abfb-1987997729fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Sulfur
Dosage form
RINSE
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-04-20
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
10; 5 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 5 Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM10 mg/g
SULFUR5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70

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
42192-136-06Sodium Sulfacetamide 10 Sulfur 5 Cleanser170.3 g in 1 BOTTLERINSE170.36
42192-136-08Sodium Sulfacetamide 10 Sulfur 5 Cleanser227 g in 1 BOTTLERINSE2276
42192-136-12Sodium Sulfacetamide 10 Sulfur 5 Cleanser340.2 g in 1 BOTTLERINSE340.26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-136-06GM - Gram42192-136cdd8ae71-f151-445f-a2ec-d55d66c4299c12013-02-13
42192-136-08GM - Gram42192-136e44f6fad-b0e4-4a33-9cdf-7a55a92a7b4512016-09-02
42192-136-12GM - Gram42192-1367a3a14af-b2ee-4dff-848c-41e0cfacc6ab12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sulfacetamide SodiumACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SulfurACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SulfacetamideACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SulfurACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-136SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [ACELLA PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 3 package rows20240112_1926eadd-d11f-44fa-971f-0041060f7589.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-136-0642192013606170.3 g in 1 BOTTLE (42192-136-06) 170.3 g2012-04-200000-00-00NoNoCurrent
42192-136-0842192013608227 g in 1 BOTTLE (42192-136-08) 227 g2016-09-190000-00-00NoNoCurrent
42192-136-1242192013612340.2 g in 1 BOTTLE (42192-136-12) 340.2 g2012-04-200000-00-00NoNoCurrent