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 52 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acne Fighting Spot with Aloe clear SALICYLIC ACID Zhejiang Ayan Biotech Co.,Ltd. db0054b1-29b9-48fa-8a02-86683bae8134 2023-11-21 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Clarifying Acne Cleanser SALICYLIC ACID Galderma Laboratories, L.P. 9add83f2-7da6-4cd0-b91b-f6c937a56255 2023-11-20 Warnings Exact identifier application number: M006 Dr. Gross AB Acne Daily Breakout SALICYLIC ACID Topiderm, Inc 79d7f1f6-d08f-4be0-afc1-9ab4338a954d 2023-11-20 Warnings Exact identifier application number: M006 Dr. Dennis Gross Alpha Beta On the Spot Eliminator SALICYLIC ACID Topiderm, Inc e0dccdbc-56fd-4034-b479-f2a2ebde2234 2023-11-16 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Triple-Action Acne Serum SALICYLIC ACID Galderma Laboratories, L.P. 3e6eb59f-c523-460e-87ed-750b4a8cacac 2023-11-16 Warnings Exact identifier application number: M006 Medicated Wash SALICYLIC ACID Vivier Pharma, Inc. e90ab8b6-6a77-4e02-9d71-45cd7383cb0a 2023-11-14 Warnings Exact identifier application number: M006 GOODBYE ACNE Complete treatment gel SALICYLIC ACID Peter Thomas Roth, LLC 09b88031-f5fe-8ae1-e063-6394a90a8a6a 2023-11-14 Warnings Exact identifier application number: M006 L BRI Pure n Natural Deep Clean Toner SALICYLIC ACID L'BRI HEALTH AND BEAUTY INC 353e948e-da5d-4c15-adcb-77ef978cf05f 2023-11-11 Warnings Exact identifier application number: M006 MD-Acne Body Acne Treatment BENZOYL PEROXIDE MD Algorithms Inc. 97981e9b-d56a-42f6-a75f-647b4732021e 2023-11-11 Warnings Exact identifier application number: M006 ACNE THERAPY BENZOYL PEROXIDE menScience Androceuticals, LLC 4dec259d-200e-44f2-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M006 HUMANE Acne Spot Treatment BENZOYL PEROXIDE Apprendista, LLC ceeb398e-c516-45e4-a21c-cbecf6206fcc 2023-11-11 Warnings Exact identifier application number: M006 VANIBISS BUTT and THIGHS Acne Treatment Cream SALICYLIC ACID Vanibiss Inc a0a75b54-e484-4e89-bdf2-e2c864cd2734 2023-11-11 Warnings Exact identifier application number: M006 SIMPLY VITAL Acne Face Cream SALICYLIC ACID ALPHA PLANTS INC 67c43d4a-873c-4b8e-83ff-6485d9633e7b 2023-11-11 Warnings Exact identifier application number: M006 CLARIFAST One Step Acne Treatment SALICYLIC ACID VIREO SYSTEMS, INC. b20a0f00-4bf2-4583-b399-7097542fff90 2023-11-11 Warnings Exact identifier application number: M006 5 Percent Benzoyl Peroxide Cleanser BENZOYL PEROXIDE Brand Evangelists for Beauty Limited e82469e2-606a-4263-9aaa-08596b59ff6b 2023-11-10 Warnings Exact identifier application number: M006 The INKEY List Acne Clearing Moisturizer SULFUR Brand Evangelists for Beauty Limited d26f5031-6592-4467-afc9-41c21f9f048c 2023-11-10 Warnings Exact identifier application number: M006 ACNE FORTE Acne Treatment Cream BENZOYL PEROXIDE GSCM Ventures Inc. DBA Revitol c29ed6c1-b8ad-4131-a94c-379f16ab2ee5 2023-11-10 Warnings Exact identifier application number: M006 Meijer Blackhead Clearing Scrub Acne medication SALICYLIC ACID Meijer Distribution, Inc 338e8937-e17e-4e14-b18f-2e63f5531442 2023-11-08 Warnings Exact identifier application number: M006 Acne Fighting Foundation Caramel SALICYLIC ACID Zhejiang Ayan Biotech Co.,Ltd. 92c4fe5f-fcc8-4dde-9f34-a55f53e009bb 2023-11-06 Warnings Exact identifier application number: M006 Asepxia Neutral Acne Bar SALICYLIC ACID Genomma Lab USA b3995e68-d364-4d96-8148-b456087b4297 2023-11-06 Warnings Exact identifier application number: M006
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