Home NDC 50405-850 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS: Although rare, sensitivity to Sulfacetaminde Sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS: Although rare, Sulfacetamide Sodium may cause local irritation.
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 Ingredient Strength SULFACETAMIDE SODIUM 100 mg/g SULFUR 50 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii 4NRT660KJQ, 70FD1KFU70 Rxcui 999613
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50405-850-01 Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 170 g in 1 BOTTLE LIQUID 170 1 50405-850-02 Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 340 g in 1 BOTTLE LIQUID 340 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50405-850 SODIUM SULFACETAMIDE 10 % AND SULFUR 5 % CLEANSER (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [SOHM, INC] 1 Current NDC, 2 package rows 20230504_dc4f3e25-a39d-4965-80e8-4fe2361a67d0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50405-850-01 50405085001 170 g in 1 BOTTLE (50405-850-01) 170 g 2023-04-30 No No Current 50405-850-02 50405085002 340 g in 1 BOTTLE (50405-850-02) 340 g 2023-04-30 No No Current