FDA.reportPublic FDA data

SODIUM SULFACETAMIDE

Product NDC
44523-606
11-digit product format
445230606
Labeler code
44523
Product ID
44523-606_4629294b-c757-6477-e063-6294a90a3d5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-01-07
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ
Rxcui1006107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44523-606-122024-03-06C16284748780-11030e365-244c-111a-e063-dadaa90a10e2SODIUM SULFACETAMIDE 10% WASH
44523-606-162024-03-06C16284748780-11030e365-244c-111a-e063-dadaa90a10e2SODIUM SULFACETAMIDE 10% WASH
44523-606-122024-01-30C16284748780-11030e365-244c-111a-e063-dadaa90a10e2SODIUM SULFACETAMIDE 10% WASH
44523-606-162024-01-30C16284748780-11030e365-244c-111a-e063-dadaa90a10e2SODIUM SULFACETAMIDE 10% WASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-606-12SODIUM SULFACETAMIDE355 mL in 1 BOTTLE, PLASTICLIQUID3557
44523-606-16SODIUM SULFACETAMIDE473 mL in 1 BOTTLE, PLASTICLIQUID4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-606-12ML - Milliliter44523-606d4e6a224-9d24-4677-89e8-ebe358bab08d12013-10-17
44523-606-16ML - Milliliter44523-6067104460f-623b-4f14-bf83-1c3c02883b8312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESINACTIVE INGREDIENTGO50W2HWO8SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-606SODIUM SULFACETAMIDE LIQUID [BIOCOMP PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20240308_d8954bfa-2acf-445a-9810-62cfd5d469b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNd8954bfa-2acf-445a-9810-62cfd5d469b37
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDd8954bfa-2acf-445a-9810-62cfd5d469b37
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYd8954bfa-2acf-445a-9810-62cfd5d469b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-606-1244523060612355 mL in 1 BOTTLE, PLASTIC (44523-606-12) 355 ml2013-01-070000-00-00NoNoCurrent
44523-606-1644523060616473 mL in 1 BOTTLE, PLASTIC (44523-606-16) 473 ml2013-01-070000-00-00NoNoCurrent