Home NDC 28595-501 sulfacetamide sodium and sulfur
Product NDC 28595-501
11-digit product format 285950501
Labeler code 28595
Product ID 28595-501_4a912755-c660-18d3-e063-6294a90a1a38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfacetamide sodium and sulfur
Dosage form SUSPENSION
Route TOPICAL
Labeler Allegis Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-06-18
Substance SULFACETAMIDE SODIUM; SULFUR
Active strength 90; 42.5 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base sulfacetamide sodium and sulfur
Brand name suffix Sodium Sulfacetamide - Sulfur
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 90 mg/mL SULFUR 42.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2531383 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28595-501-08 sulfacetamide sodium and sulfurSodium Sulfacetamide - Sulfur 237 mL in 1 BOTTLE SUSPENSION 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-501 SULFACETAMIDE SODIUM AND SULFUR SODIUM SULFACETAMIDE - SULFUR (SULFACETAMIDE SODIUM AND SULFUR) SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20240619_1aa1025f-c568-34d3-e063-6394a90a37b8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 28595-501-08 28595050108 237 mL in 1 BOTTLE (28595-501-08) 237 ml 2024-06-18 No No Current