FDA.reportPublic FDA data

SODIUM SULFACETAMIDE - SULFUR WASH

Product NDC
42192-121
11-digit product format
421920121
Labeler code
42192
Product ID
42192-121_5f0c9397-a5f3-44d6-933e-10eda34274c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
ACELLA PHARMACEUTICALS
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-09-16
Substance
SULFACETAMIDE; SULFUR
Active strength
90; 40 mg/473.2mL; mg/473.2mL
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 WASH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE90 mg/473.2mL
SULFUR40 mg/473.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4965G3J0F5, 70FD1KFU70
Rxcui1001714

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd012da9-cd07-4d66-b6f1-ce3bdc2a3665Product name120210312
3d59dc1e-80a4-4b1f-b3e1-387c65c31efbProduct name320200619
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
a4fffefe-232a-3e06-c77d-1e6fdaec7d5eProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-121-16SODIUM SULFACETAMIDE - SULFUR WASH473.2 mL in 1 BOTTLELIQUID473.27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-121SODIUM SULFACETAMIDE - SULFUR WASH (SODIUM SULFACETAMIDE, SULFUR) LIQUID [ACELLA PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20240112_d9c5e993-e82a-436f-bd95-8984935c6551.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001714sulfacetamide sodium 9 % / sulfur 4 % Medicated Liquid SoapPSNd9c5e993-e82a-436f-bd95-8984935c65517
1001714sulfacetamide sodium 90 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDd9c5e993-e82a-436f-bd95-8984935c65517
1001714sulfacetamide sodium 9 % / sulfur 4 % Medicated Liquid SoapSYd9c5e993-e82a-436f-bd95-8984935c65517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-121-1642192012116473.2 mL in 1 BOTTLE (42192-121-16) 473.2 ml2010-09-160000-00-00NoNoCurrent