FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
69367-247
Requested package NDC
69367-247-06
11-digit product format
693670247
Labeler code
69367
Product ID
69367-247_33621d74-84ee-4831-8935-95cd618398fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and sulfur
Dosage form
LIQUID
Route
TOPICAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-05-05
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
999613Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b7e2859-d149-4116-bd98-d6d096266b04Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69367-247-062024-01-30C16284748780-11030e365-09dd-111a-e063-dadaa90a10e2Sodium Sulfacetamide 10% and Sulfur 5% Cleanser
69367-247-122024-01-30C16284748780-11030e365-09dd-111a-e063-dadaa90a10e2Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-247-06SODIUM SULFACETAMIDE, SULFUR170.3 g in 1 BOTTLELIQUID170.36
69367-247-08SODIUM SULFACETAMIDE, SULFUR227 g in 1 BOTTLELIQUID2276
69367-247-12SODIUM SULFACETAMIDE, SULFUR340.2 g in 1 BOTTLELIQUID340.26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-247-06GM - Gram69367-2471ce0c10e-d0c7-42fb-9bc3-7c36b860527212020-07-13
69367-247-08GM - Gram69367-24777114718-c684-403a-a66c-ca876984490712025-08-11
69367-247-12GM - Gram69367-247e5c200f3-676e-4969-acce-209f7d8c8ef012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-247SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM AND SULFUR) LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20240704_6b7e2859-d149-4116-bd98-d6d096266b04.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 AND SULFURWestminster Pharmaceuticals, LLC6b7e2859-d149-4116-bd98-d6d096266b042025-07-01Warnings, Adverse reactionsExact identifier
ndc (package): 69367-247-06
ndc (product): 69367-247
ndc11 (package): 69367024706

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN6b7e2859-d149-4116-bd98-d6d096266b046
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD6b7e2859-d149-4116-bd98-d6d096266b046
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY6b7e2859-d149-4116-bd98-d6d096266b046
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY6b7e2859-d149-4116-bd98-d6d096266b046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-247-0669367024706170.3 g in 1 BOTTLE (69367-247-06) 170.3 g2020-05-052023-01-15NoNoCurrent