Sulfacetamide Sodium and Sulfur

Product NDC
42582-500
11-digit product format
425820500
Labeler code
42582
Product ID
42582-500_1959cc6a-4f09-4fb7-8157-32569de1cb4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM and SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Bi-Coastal Pharma International LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
90 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-500-21Sulfacetamide Sodium and Sulfur454 g in 1 BOTTLECREAM4543
42582-500-21Sulfacetamide Sodium and Sulfur1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-500-21GM - Gram42582-500e1958787-4bb8-4e81-aedc-cc14a1561a1512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFURACTIVE MOIETY70FD1KFU70SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEINACTIVE INGREDIENT5M1101WGSYSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-500SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 2 package rows20220118_5f633aac-6f6a-467a-8047-9b5f1929d00b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-500-21425820500211 BOTTLE in 1 CARTON (42582-500-21) > 454 g in 1 BOTTLE1 bottle2011-06-010000-00-00NoNoCurrent