FDA.reportPublic FDA data

24 Hour Sensitive Skin Acne Clearing System

Product NDC
80861-118
11-digit product format
808610118
Labeler code
80861
Product ID
80861-118_57f4be73-2f08-800a-e063-6294a90a1232
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
KIT
Labeler
Acne Free LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-14
NDC exclude flag
No
Listing certified through
2027-12-31
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
24 Hour Sensitive Skin Acne Clearing System
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
422997Internal RxNorm lookup
1234456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39ea674d-ff6e-a8c6-e063-6394a90a0656Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-008-0124 Hour Sensitive Skin Acne Clearing System118 mL in 1 BOTTLELOTION118 mL15 mg in 1mL1
80861-118-0124 Hour Sensitive Skin Acne Clearing System1 in 1 KITKIT11
80861-119-0124 Hour Sensitive Skin Acne Clearing System59 mL in 1 BOTTLELOTION59 mL15 mg in 1mL1

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 10 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDEAmazon.com Services LLC2dddc0ef-352a-4973-8402-15aecddcc43f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M006
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
application number: M006
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
application number: M006
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.464c0ed1-ebc4-45b1-80e3-dfe0b76312e32026-03-17WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Stubborn Acne SpotBENZOYL PEROXIDEKenvue Brands LLC5b11b2de-d156-4d6a-8024-0a945661cd9a2026-03-12WarningsExact identifier
application number: M006
Clean and Clear persa-gel 10 Maximum StrengthBENZOYL PEROXIDEKenvue Brands LLCc9642441-4d3a-1128-e053-2995a90aefd12026-03-12WarningsExact identifier
application number: M006
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
application number: M006
Body WashSALICYLIC ACIDAmazon.com Services LLCb5d7da95-81ff-4ef9-8b80-2d046cc2a6082026-03-10Warnings, Adverse reactionsExact identifier
application number: M006
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC4cb2cc1b-1793-b0c4-e063-6294a90a430f2026-03-08WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShenzhen Jindali Technology Co., Ltd4c5c3368-b3d2-976f-e063-6294a90a70462026-03-06WarningsExact identifier
application number: M006
RoyceDerm Rosacea Relief Cream.SULFUR 1X HPUS 10%RoyceDerm LLC4c3f6332-de46-f107-e063-6294a90ad63f2026-03-04WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Acne WashSALICYLIC ACIDOld East Main Co.7bf6f18f-a1ec-460e-afbc-51be1add05b62026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Advanced DermaClear SerumSALICYLIC ACIDAllure Labs4c10bc9a-52b0-fbf2-e063-6394a90a57802026-03-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234456salicylic acid 1.5 % Medicated Liquid SoapPSN39ea674d-ff6e-a8c6-e063-6394a90a06561
422997salicylic acid 1.5 % Topical LotionPSN39ea674d-ff6e-a8c6-e063-6394a90a06561
1234456salicylic acid 15 MG/ML Medicated Liquid SoapSCD39ea674d-ff6e-a8c6-e063-6394a90a06561
422997salicylic acid 15 MG/ML Topical LotionSCD39ea674d-ff6e-a8c6-e063-6394a90a06561
1234456salicylic acid 1.5 % Medicated Liquid SoapSY39ea674d-ff6e-a8c6-e063-6394a90a06561
422997salicylic acid 1.5 % Topical LotionSY39ea674d-ff6e-a8c6-e063-6394a90a06561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80861-008-0180861000801118 mL in 1 BOTTLE118 mlHistorical
80861-118-01808610118011 KIT in 1 KIT (80861-118-01) * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-119-01) 1 kit2025-07-14NoNoCurrent
80861-119-018086101190159 mL in 1 BOTTLE59 mlHistorical