Home NDC 58657-469-16 Sodium Sulfacetamide 8% and Sulfur 4% Cleanser
Product NDC 58657-469
Requested package NDC 58657-469-16
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 Ingredient Strength SULFACETAMIDE SODIUM 80 mg/mL SULFUR 40 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 1010234 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 58657-469-16 Sodium Sulfacetamide 8% and Sulfur 4% Cleanser 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-469 SODIUM SULFACETAMIDE 8% AND SULFUR 4% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [METHOD PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 1 package rows 20241126_d8dcbf63-58f0-0a25-e053-2a95a90a7633.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 Marketing end Sample Exclude flag Status 58657-469-16 58657046916 473 mL in 1 BOTTLE, PLASTIC (58657-469-16) 473 ml 2022-02-15 0000-00-00 No No Current