FDA.reportPublic FDA data

SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-600
11-digit product format
445230600
Labeler code
44523
Product ID
44523-600_2c6307dd-ff18-0654-e063-6294a90afc15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-01-23
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 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 AND SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 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
1494174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c631307-b8a3-2978-e063-6394a90a79c3Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-600-02SODIUM SULFACETAMIDE AND SULFUR57 g in 1 BOTTLE, PLASTICLOTION571
44523-600-02SODIUM SULFACETAMIDE AND SULFUR1 in 1 CARTONLOTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-600-02GM - Gram44523-6003ee74ae3-3527-47ed-81d2-f875934816ca12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-600SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1Current NDC, 2 package rows20250125_2c631307-b8a3-2978-e063-6394a90a79c3.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.2c631307-b8a3-2978-e063-6394a90a79c32025-01-23Warnings, Adverse reactionsExact identifier
ndc (product): 44523-600

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionPSN2c631307-b8a3-2978-e063-6394a90a79c31
1494174sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Topical LotionSCD2c631307-b8a3-2978-e063-6394a90a79c31
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionSY2c631307-b8a3-2978-e063-6394a90a79c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
44523-600-02445230600021 BOTTLE, PLASTIC in 1 CARTON (44523-600-02) / 57 g in 1 BOTTLE, PLASTIC2025-01-23NoNoCurrent