Home NDC 84463-507 LEROSETT Botanical Acne Cleanser
Product NDC 84463-507
11-digit product format 844630507
Labeler code 84463
Product ID 84463-507_1bdb4533-5607-1d70-e063-6294a90a8b37
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form GEL
Route TOPICAL
Labeler GUNILLA OF SWEDEN, INC.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-20
Substance SALICYLIC ACID
Active strength 20 mg/mL
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 LEROSETT Botanical Acne Cleanser
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562600 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 84463-507-00 LEROSETT Botanical Acne Cleanser 200 mL in 1 BOTTLE GEL 200 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84463-507 LEROSETT BOTANICAL ACNE CLEANSER (SALICYLIC ACID) GEL [GUNILLA OF SWEDEN, INC.] 1 Current NDC, 1 package rows 20240628_8b31d155-c257-4452-9e22-0c69fa36173e.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 37 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 84463-507-00 84463050700 200 mL in 1 BOTTLE (84463-507-00) 200 ml 2024-06-20 No No Current