FDA.reportPublic FDA data

Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser

Product NDC
50405-850
11-digit product format
504050850
Labeler code
50405
Product ID
50405-850_33c53704-fdee-4209-ac08-24ab0e8ebfd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide and Sulfur
Dosage form
LIQUID
Route
TOPICAL
Labeler
SOHM, Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-04-30
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 10 % and Sulfur 5 % Cleanser
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50405-850-01Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser170 g in 1 BOTTLELIQUID1701
50405-850-02Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser340 g in 1 BOTTLELIQUID3401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-850SODIUM SULFACETAMIDE 10 % AND SULFUR 5 % CLEANSER (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [SOHM, INC]1Current NDC, 2 package rows20230504_dc4f3e25-a39d-4965-80e8-4fe2361a67d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYdc4f3e25-a39d-4965-80e8-4fe2361a67d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50405-850-0150405085001170 g in 1 BOTTLE (50405-850-01) 170 g2023-04-30NoNoCurrent
50405-850-0250405085002340 g in 1 BOTTLE (50405-850-02) 340 g2023-04-30NoNoCurrent