FDA.reportPublic FDA data

SULFACETAMIDE SODIUM, SULFUR

Product NDC
44523-560
11-digit product format
445230560
Labeler code
44523
Product ID
44523-560_45b4c03d-8b8d-8b9e-e063-6294a90a1699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
EMULSION
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
SULFACETAMIDE SODIUM, 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
Rxcui999613

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-560-06SULFACETAMIDE SODIUM, SULFUR170 g in 1 BOTTLE, PLASTICEMULSION1707
44523-560-08SULFACETAMIDE SODIUM, SULFUR227 g in 1 BOTTLE, PLASTICEMULSION2277
44523-560-12SULFACETAMIDE SODIUM, SULFUR340 g in 1 BOTTLE, PLASTICEMULSION3407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-560-06GM - Gram44523-560ceb17c39-cf6e-40fb-ad06-903e1b66c91c12023-12-05
44523-560-08GM - Gram44523-56093e713f5-82f3-4784-a0a7-0871ee0697ee12013-12-02
44523-560-12GM - Gram44523-560115818d8-c16b-4985-b3ad-ae3e95c6b2be12023-12-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
HECTORITEINACTIVE INGREDIENT08X4KI73EZSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-560SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]6Current NDC, Legacy NDC, 3 package rows20231108_0ea3cd84-de0f-4981-a420-1d01d1ecd620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY0ea3cd84-de0f-4981-a420-1d01d1ecd6207

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-560-0644523056006170 g in 1 BOTTLE, PLASTIC (44523-560-06) 170 g2011-09-15NoNoCurrent
44523-560-0844523056008227 g in 1 BOTTLE, PLASTIC (44523-560-08) 227 g2011-09-150000-00-00NoNoCurrent
44523-560-1244523056012340 g in 1 BOTTLE, PLASTIC (44523-560-12) 340 g2011-09-15NoNoCurrent