FDA.reportPublic FDA data

NDC 80861-008 - 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
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

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 117 of 120 · 2,391 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Cold Sore Fever Blister TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)c17cc31f-bd2e-4da2-bba4-54b6b8b1ebf72022-12-01WarningsExact identifier
unii: 9G1OE216XY
Cold Sore TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)a46e4d60-e84b-44a9-9d54-4861dbe91c592022-12-01WarningsExact identifier
unii: 9G1OE216XY
Immune SupportARSENICUM ALBUM, RUMEX, SQUILLA MARITIMA, BRYONIA ALBA, KALI CARBONICUM, GLUTATHIONE, VITAMIN C, VITAMIN C, ZINC PICOLINATE, VITAMIN B, VITAMIN E, BETA GLUCAN, CURCUMIN, GRAPEFRUIT SEED, OREGANO LEAF, GARLIC BULB, OLIVE LEAF, APPLE CIDER VINEGAR, ASTRAGALUS ROOT, MAITAKE MUSHROOM, CATS CLAW BARKProBLENe6f26cf4-dc3d-4d31-aa3e-145167b6ba2b2022-11-30WarningsExact identifier
unii: QN83US2B0N
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Real Relief Natural Wellness Calming SyrupASAFOETIDA, STRYCHNOS IGNATII SEED (IGNATIA AMARA), VALERIANA OFFICINALIS WHOLE (VALERIANA OFFICINALIS), OAT BRAN (AVENA SATIVA), SILVER NITRATE (ARGENTUM NITRICUM), HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT (PAEONIA OFFICINALIS), DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE (COCCULUS INDICUS)Homeolab International (Canada) incfb8c8d6d-3c7a-459d-97a8-d9094f3d546c2022-11-03WarningsExact identifier
unii: KQX236OK4U
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DocosanolDOCOSANOLCare One (Retail Business Services, LLC.)3587f8f0-99ab-4493-adde-0dfd0911170d2022-10-21WarningsExact identifier
unii: 9G1OE216XY
Cold Sore TreatmentDOCOSANOLP & L Development, LLC15d1a6c5-4a61-48f3-b45e-a7e34cbeb2942022-10-18WarningsExact identifier
unii: 9G1OE216XY
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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