FDA.reportPublic FDA data

Sodium Sulfacetamide 8% and Sulfur 4% Cleanser

Product NDC
58657-469
11-digit product format
586570469
Labeler code
58657
Product ID
58657-469_4aad590b-719f-0039-e063-6294a90a7fc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Method Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-02-01
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
80; 40 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide 8% and Sulfur 4% Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM80 mg/mL
SULFUR40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1010234

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
58657-469-16Sodium Sulfacetamide 8% and Sulfur 4% Cleanser473 mL in 1 BOTTLE, PLASTICLIQUID4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-469SODIUM SULFACETAMIDE 8% AND SULFUR 4% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [METHOD PHARMACEUTICALS]6Current NDC, Legacy NDC, 1 package rows20241126_d8dcbf63-58f0-0a25-e053-2a95a90a7633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYfb0c9508-0ff1-46eb-8df0-4bfd2c123187101
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNd8dcbf63-58f0-0a25-e053-2a95a90a76338
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDd8dcbf63-58f0-0a25-e053-2a95a90a76338
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYd8dcbf63-58f0-0a25-e053-2a95a90a76338
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYd8dcbf63-58f0-0a25-e053-2a95a90a76338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-469-1658657046916473 mL in 1 BOTTLE, PLASTIC (58657-469-16) 473 ml2022-02-150000-00-00NoNoCurrent