FDA.reportPublic FDA data

Sodium Sulfacetamide, Sulfur

Product NDC
44523-550
11-digit product format
445230550
Labeler code
44523
Product ID
44523-550_f798f8d7-639f-2a12-e053-6294a90a00fb
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; 20 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
SULFUR20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1000895

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
44523-550-08Sodium Sulfacetamide, Sulfur227 g in 1 BOTTLE, PLASTICEMULSION2275

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-550-08GM - Gram44523-550aef152df-2fb2-4e70-8f2b-24ded3e2442812013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
HECTORITEINACTIVE INGREDIENT08X4KI73EZSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-550SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20230825_99e52390-478e-49ed-87de-aa794379bfeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapPSN99e52390-478e-49ed-87de-aa794379bfeb5
1000895sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Medicated Liquid SoapSCD99e52390-478e-49ed-87de-aa794379bfeb5
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapSY99e52390-478e-49ed-87de-aa794379bfeb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-550-0844523055008227 g in 1 BOTTLE, PLASTIC (44523-550-08) 227 g2011-09-150000-00-00NoNoCurrent