Home NDC 71399-0487-6 Sodium Sulfacetamide 8% and Sulfur 4%
Product NDC 71399-0487
Requested package NDC 71399-0487-6
11-digit product format 713990487
Labeler code 71399
Product ID 71399-0487_a4bb29b0-065f-428b-9d9b-bb4e564449d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFACETAMIDE SODIUM, SULFUR
Dosage form SUSPENSION
Route TOPICAL
Labeler Akron Pharma Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-09-13
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Sodium Sulfacetamide 8% and Sulfur 4%
Listing expiration 2026-12-31 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 71399-0487-6 Sodium Sulfacetamide 8% and Sulfur 4% 473 mL in 1 BOTTLE, PLASTIC SUSPENSION 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71399-0487 SODIUM SULFACETAMIDE 8% AND SULFUR 4% (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [AKRON PHARMA INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240926_bfbe625c-5679-4363-913a-2ab03198f4f0.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 71399-0487-6 71399048706 473 mL in 1 BOTTLE, PLASTIC (71399-0487-6) 473 ml 2024-09-13 0000-00-00 No No Current