FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
69367-247
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

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 Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui999613

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

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 g2020-05-050000-00-00NoNoCurrent
69367-247-0869367024708227 g in 1 BOTTLE (69367-247-08) 227 g2025-06-30NoNoCurrent
69367-247-1269367024712340.2 g in 1 BOTTLE (69367-247-12) 340.2 g2020-05-050000-00-00NoNoCurrent