FDA.reportPublic FDA data

Sodium Sulfacetamide, Sulfur

Product NDC
44523-542
11-digit product format
445230542
Labeler code
44523
Product ID
44523-542_462a018f-3144-d7e4-e063-6394a90ae008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
CREAM
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 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, Sulfur
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005834

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
44523-542-02Sodium Sulfacetamide, Sulfur57 g in 1 BOTTLE, PLASTICCREAM575

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-542-02GM - Gram44523-5426395ffa2-b4f8-494a-8e1c-89fee9b61ad612013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
ISOSTEARYL PALMITATEINACTIVE INGREDIENT9EHU0R7ER1SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-542SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM) CREAM [BIOCOMP PHARMA, INC.]4Current NDC, Legacy NDC, 1 package rows20230817_ed616ece-09b5-41d5-ae58-8e016da2c6b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSNed616ece-09b5-41d5-ae58-8e016da2c6b35
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCDed616ece-09b5-41d5-ae58-8e016da2c6b35
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSYed616ece-09b5-41d5-ae58-8e016da2c6b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-542-024452305420257 g in 1 BOTTLE, PLASTIC (44523-542-02) 57 g2011-09-150000-00-00NoNoCurrent