FDA.reportPublic FDA data

Sodium Sulfacetamide and Sulfur

Product NDC
69367-245
11-digit product format
693670245
Labeler code
69367
Product ID
69367-245_b4e89e57-397a-4578-bc59-709cb46db033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide and Sulfur
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-06-18
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
80; 40 mg/mL; 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 and Sulfur
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM80 mg/mL
SULFUR40 mg/mL

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
1010234Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9b60d3f-3f3f-477d-92d7-fe0ba07e21deAvailable 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
69367-245-16Sodium Sulfacetamide and Sulfur473 mL in 1 BOTTLESUSPENSION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-245-16ML - Milliliter69367-245148e5b1b-6e6f-4141-8147-1d3d4b62effd12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-245SODIUM SULFACETAMIDE AND SULFUR SUSPENSION [WESTMINSTER PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 1 package rows20250501_e9b60d3f-3f3f-477d-92d7-fe0ba07e21de.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 AND SULFURWestminster Pharmaceuticals, LLCe9b60d3f-3f3f-477d-92d7-fe0ba07e21de2025-04-29Warnings, Adverse reactionsExact identifier
ndc (product): 69367-245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNe9b60d3f-3f3f-477d-92d7-fe0ba07e21de8
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDe9b60d3f-3f3f-477d-92d7-fe0ba07e21de8
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYe9b60d3f-3f3f-477d-92d7-fe0ba07e21de8
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYe9b60d3f-3f3f-477d-92d7-fe0ba07e21de8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-245-1669367024516473 mL in 1 BOTTLE (69367-245-16) 473 ml2021-06-180000-00-00NoNoCurrent