FDA.reportPublic FDA data

NDC 80861-008-01 - 24 Hour Sensitive Skin Acne Clearing System

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80861-008
Requested NDC
80861-008-01
Package NDCs from labels
80861-008-01
Manufacturer
Acne Free LLC
Effective date
2026-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
24 Hour Sensitive Skin Acne Clearing System - Acne Free LLCAcne Free LLC2026-07-31HUMAN OTC DRUG LABEL
Acne Free SENSITIVE SKIN 24 HR Acne Clearing System - AcneFree LLCAcneFree LLC2026-07-31HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-008-01Acne Free SENSITIVE SKIN 24 HR Acne Clearing System118 mL in 1 BOTTLELOTION118 mL15 mg in 1mL6
80861-008-0124 Hour Sensitive Skin Acne Clearing System118 mL in 1 BOTTLELOTION118 mL15 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-008ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM (SALICYLIC ACID, BENZOYL PEROXIDE) KIT [ACNEFREE LLC]5Unmatched20240620_c9397a25-8fed-48d0-e053-2a95a90ab495.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 33 of 136 · 2,718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tuymec Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOO.Guangzhou Jingliang Cosmetics Co., Ltd.4ae93408-5c8f-c0a5-e063-6394a90a9e0d2026-02-15WarningsExact identifier
unii: O414PZ4LPZ
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC4ac42528-9210-6936-e063-6294a90a41682026-02-14WarningsExact identifier
unii: O414PZ4LPZ
iShancare Folliculitis CreamFOLLICULITIS CREAMShenzhen Ishan Technology Co., Ltd0c85c8e9-f50f-1b72-e063-6394a90a88c42026-02-13WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: W9WZN9A0GM
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: W9WZN9A0GM
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
unii: O414PZ4LPZ
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact identifier
unii: O414PZ4LPZ
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
unii: W9WZN9A0GM
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
iShanCare Folliculitis CleansingISHANCARE FOLLICULITIS CLEANSINGShenzhen Ishan Technology Co., Ltd3ca2ffbc-1cdc-0ebd-e063-6394a90af47a2026-02-12WarningsExact identifier
unii: VIF565UC2G
HOMWIS Eczema ReliefECZEMA RELIEF SOAPShenzhen Ishan Technology Co., Ltd3ca0d0f2-55cd-09f2-e063-6294a90ac56f2026-02-12WarningsExact identifier
unii: VIF565UC2G
iShanCare COLD SORE TREATMENTCOLD SORE TREATMENTShenzhen Ishan Technology Co., Ltd3a7ddfe4-8b2e-898e-e063-6394a90ac6402026-02-12WarningsExact identifier
unii: 9G1OE216XY
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
unii: O414PZ4LPZ
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
unii: O414PZ4LPZ
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.