Sodium Sulfacetamide, Sulfur

Product NDC
44523-520
Requested package NDC
44523-520-02
11-digit product format
445230520
Labeler code
44523
Product ID
44523-520_2d7f2b22-c0bb-6b29-e063-6394a90aae2e
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
2011-09-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage44523-52044523-520-02DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage44523-52044523-520-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
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
c735ff03-c97c-430d-a37b-5b40cf29046aAvailable 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
44523-520-02Sodium Sulfacetamide, Sulfur1 in 1 CARTONCREAM16
44523-520-02Sodium Sulfacetamide, Sulfur57 g in 1 BOTTLE, PLASTICCREAM576

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-520-02GM - Gram44523-5202aa9d4c3-1730-45a0-8b76-81a5e8e4140712013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
ISOSTEARYL PALMITATEINACTIVE INGREDIENT9EHU0R7ER1SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-520SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20250209_c735ff03-c97c-430d-a37b-5b40cf29046a.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, SulfurSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.c735ff03-c97c-430d-a37b-5b40cf29046a2025-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 44523-520-02
ndc (product): 44523-520
ndc11 (package): 44523052002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSNc735ff03-c97c-430d-a37b-5b40cf29046a6
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCDc735ff03-c97c-430d-a37b-5b40cf29046a6
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSYc735ff03-c97c-430d-a37b-5b40cf29046a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-520-024452305200257 g in 1 BOTTLE, PLASTIC (44523-520-02) 57 g2011-09-150000-00-00NoNoCurrent