Sodium Sulfacetamide and Sulfur Cleanser

Product NDC
42582-800
11-digit product format
425820800
Labeler code
42582
Product ID
42582-800_1105962f-1a95-44ef-9e69-d61f5a501eb7
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
100 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
42582-800-08Sodium Sulfacetamide and Sulfur Cleanser227 g in 1 BOTTLECREAM2273

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-800-08GM - Gram42582-80058760bc1-ad1c-4a09-8a3b-a97ed2ec61bc12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEINACTIVE INGREDIENT5M1101WGSYSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-800SODIUM SULFACETAMIDE AND SULFUR CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 1 package rows20220118_1aa63fb0-05d9-426a-aa45-264373a23d9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapPSN1aa63fb0-05d9-426a-aa45-264373a23d9f3
1000895sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Medicated Liquid SoapSCD1aa63fb0-05d9-426a-aa45-264373a23d9f3
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapSY1aa63fb0-05d9-426a-aa45-264373a23d9f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-800-0842582080008227 g in 1 BOTTLE (42582-800-08) 227 g2011-06-010000-00-00NoNoCurrent