FDA.reportPublic FDA data

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser

Product NDC
52187-546
11-digit product format
521870546
Labeler code
52187
Product ID
52187-546_db857027-0176-e452-e053-2995a90a4df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-03-31
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 9.8% and Sulfur 4.8% Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1494169

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
52187-546-10Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser285 g in 1 BOTTLE, PLASTICLIQUID2851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-546-10GM - Gram52187-546c80b4c16-6231-4034-809c-41df9a19bb0e12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-546SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 1 package rows20220402_db857027-0175-e452-e053-2995a90a4df5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapPSNdb857027-0175-e452-e053-2995a90a4df51
1494169sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Medicated Liquid SoapSCDdb857027-0175-e452-e053-2995a90a4df51
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapSYdb857027-0175-e452-e053-2995a90a4df51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-546-1052187054610285 g in 1 BOTTLE, PLASTIC (52187-546-10) 285 g2022-03-310000-00-00NoNoCurrent