SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-603
Requested package NDC
44523-603-01
11-digit product format
445230603
Labeler code
44523
Product ID
44523-603_47e82f4d-fd8f-6276-e063-6394a90af3b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-04-30
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
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
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1005834Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebd8d6a4-ecd8-402e-b0b7-ceb9047c83d4Available on FDA.report

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
44523-603-01SODIUM SULFACETAMIDE AND SULFUR28 g in 1 BOTTLE, PLASTICCREAM286
44523-603-01SODIUM SULFACETAMIDE AND SULFUR1 in 1 CARTONCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-603SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 2 package rows20230926_ebd8d6a4-ecd8-402e-b0b7-ceb9047c83d4.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 SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.ebd8d6a4-ecd8-402e-b0b7-ceb9047c83d42026-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 44523-603-01
ndc (product): 44523-603
ndc11 (package): 44523060301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSNebd8d6a4-ecd8-402e-b0b7-ceb9047c83d46
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCDebd8d6a4-ecd8-402e-b0b7-ceb9047c83d46
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSYebd8d6a4-ecd8-402e-b0b7-ceb9047c83d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44523-603-01445230603011 BOTTLE, PLASTIC in 1 CARTON (44523-603-01) / 28 g in 1 BOTTLE, PLASTIC2011-04-300000-00-00NoNoCurrent