Home NDC 85439-0102 Sulfur Spot Treatment
Product NDC 85439-0102
11-digit product format 854390102
Labeler code 85439
Product ID 85439-0102_31e527e0-ce38-e920-e063-6394a90ac827
Type HUMAN OTC DRUG
Nonproprietary name Sulfur Acne Treatment
Dosage form CREAM
Route TOPICAL
Labeler Banuskin, Inc.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-15
Substance SULFUR
Active strength 10 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Sulfur Spot Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 315220 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 85439-0102-1 Sulfur Spot Treatment 15 mL in 1 TUBE CREAM 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85439-0102 SULFUR SPOT TREATMENT (SULFUR ACNE TREATMENT) CREAM [BANUSKIN, INC.] 1 Current NDC, 1 package rows 20250417_31e527e0-ce37-e920-e063-6394a90ac827.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 25 of 55 · 1,088 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 85439-0102-1 85439010201 15 mL in 1 TUBE (85439-0102-1) 15 ml 2025-04-15 No No Current