FDA.reportPublic FDA data

NDC 80861-004-01 - Acne Free Free 24 HR 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
80861-004
Requested NDC
80861-004-01
Package NDCs from labels
80861-004-01
Manufacturer
AcneFree, 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
Acne Free Free 24 HR Acne Clearing System - AcneFree, LLCAcneFree, LLC2026-07-31HUMAN OTC DRUG LABEL
BENZOYL PEROXIDE - AcneFree, LLCAcneFree, LLC2026-07-31HUMAN OTC DRUG LABEL
Acne Free SEVERE ACNE 24 HR Acne Clearing System - AcneFree, LLCAcneFree, LLC2026-07-31HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-004-01Acne Free Free 24 HR Acne Clearing System118 mL in 1 BOTTLEGEL118 mL25 mg in 1mL7
80861-004-01Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser118 mL in 1 BOTTLEGEL118 mL25 mg in 1mL6
80861-004-01Acne Free SEVERE ACNE 24 HR Acne Clearing System118 mL in 1 BOTTLEGEL118 mL25 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-004ACNE FREE FREE 24 HR ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC]6Unmatched20241123_c939847a-72eb-96fa-e053-2a95a90a4f9c.zip
80861-004ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC]5Unmatched20240620_c939681e-ea93-31ce-e053-2a95a90a8c70.zip
80861-004OIL FREE DEEP CLEANSING DUO CLEANSING BRUSH OIL FREE ACNE CLEANSER (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC]5Unmatched20240620_c7a675fa-b6c0-6237-e053-2a95a90a0406.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 8 of 325 · 6,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-08-25WarningsExact identifier
unii: 3K9958V90M
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
unii: 3K9958V90M
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands, LLC59cea08d-299a-2f50-e063-6394a90a6e142026-08-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
unii: F5UM2KM3W7
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: FGL3685T2X
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
unii: F5UM2KM3W7
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer STRAWBERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9b0101ef-54cf-466e-8c27-4429d5cf4d172026-08-21WarningsExact identifier
unii: 3K9958V90M
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
unii: F5UM2KM3W7
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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