SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-605
Requested package NDC
44523-605-16
11-digit product format
445230605
Labeler code
44523
Product ID
44523-605_4837c1d3-30b4-4599-e063-6394a90afdbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium sulfacetamide, sulfur
Dosage form
LOTION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-04-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
90; 45 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFACETAMIDE AND SULFUR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR90 mg/g
SULFACETAMIDE SODIUM45 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup
4NRT660KJQInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
61e1497d-40ff-0c87-e053-2991aa0a2943Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-605-16SODIUM SULFACETAMIDE AND SULFUR454 g in 1 BOTTLE, PLASTICLOTION4544

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-605-16GM - Gram44523-6051af593c9-531f-4051-9bd7-a7730f9a713b12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEINACTIVE INGREDIENT5M1101WGSYSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ISODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) KIT [BIOCOMP PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-605SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE, SULFUR) LOTION [BIOCOMP PHARMA, INC.]3Current NDC, Legacy NDC, 1 package rows20230817_61e1497d-40ff-0c87-e053-2991aa0a2943.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE AND SULFURSODIUM SULFACETAMIDE, SULFURBioComp Pharma, Inc.61e1497d-40ff-0c87-e053-2991aa0a29432026-01-12Warnings, Adverse reactionsExact identifier
ndc (package): 44523-605-16
ndc (product): 44523-605
ndc11 (package): 44523060516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-605-1644523060516454 g in 1 BOTTLE, PLASTIC (44523-605-16) 454 g2011-04-150000-00-00NoNoCurrent