FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
52187-536
11-digit product format
521870536
Labeler code
52187
Product ID
52187-536_ba0fc821-1fc3-20f9-e053-2a95a90ad977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE, SULFUR
Dosage form
RINSE
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-01-29
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
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
52187-536-06SODIUM SULFACETAMIDE, SULFUR170.3 g in 1 BOTTLERINSE170.31
52187-536-12SODIUM SULFACETAMIDE, SULFUR340.2 g in 1 BOTTLERINSE340.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-536SODIUM SULFACETAMIDE, SULFUR RINSE [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20210131_ba0fc821-1fc2-20f9-e053-2a95a90ad977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYba0fc821-1fc2-20f9-e053-2a95a90ad9771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-536-0652187053606170.3 g in 1 BOTTLE (52187-536-06) 170.3 g2021-01-290000-00-00NoNoCurrent
52187-536-1252187053612340.2 g in 1 BOTTLE (52187-536-12) 340.2 g2021-01-290000-00-00NoNoCurrent