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 119 of 120 · 2,391 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
unii: O414PZ4LPZ
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
unii: O414PZ4LPZ
Tinnitus ReliefCINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.Homeocare Laboratories30d67273-b9ec-4f3e-ace6-87a68325aaf12019-02-28WarningsExact identifier
unii: O414PZ4LPZ
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
NAS MAX STRENGTH SPOT TREATMENTSALICYLIC ACIDBURT'S BEES, INC.316a2d5e-4c7e-4b61-e054-00144ff88e882018-12-03WarningsExact identifier
unii: O414PZ4LPZ
Cover FX Mattifying Primer Plus Acne TreatmentSALICYLIC ACIDCover FX Skin Care Inc7bcf8a39-9c98-13bc-e053-2991aa0a3beb2018-11-29WarningsExact identifier
unii: O414PZ4LPZ
Acne Advanced CleansingSALICYLIC ACIDEminence Organic Skin Care Ltd.75ad5eab-8035-41c5-b6b1-ad85fa26fc3a2018-11-14WarningsExact identifier
unii: O414PZ4LPZ
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
Salicylic AcidSALICYLIC ACIDD3 Development, Inc.6b650f3d-a242-7a30-e053-2991aa0a777e2018-05-04WarningsExact identifier
unii: O414PZ4LPZ
Well at Walgreens Blemish and Blackhead Control ApricotSALICYLIC ACIDWalgreen Company17a4de6f-3fb4-40e7-9edc-fbbf2edca0222018-04-18WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidSALICYLIC ACIDKMM Pharmaceuticals, LLC17b570e7-3cf8-2f20-e054-00144ff8d46c2017-12-18Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Overnight ClearingSALICYLIC ACIDDermalogica, Inc.6f6d9bd9-a1c8-4f8c-b7b8-fe9748a06c2c2017-12-04WarningsExact identifier
unii: O414PZ4LPZ
Acne Cleanser W/ Salicylic AcidSALICYLIC ACIDAllure Labs, Inc6f831f09-03c2-49a4-b677-6260057771262017-12-01WarningsExact identifier
unii: O414PZ4LPZ
SALICYLIC ACIDSALICYLIC ACIDKMM Pharmaceuticals, LLC5df4c5b6-3ad2-7f2c-e053-2991aa0a021b2017-11-14Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: O414PZ4LPZ
unii: PDC6A3C0OX
XALIXSALICYLIC ACIDKMM Pharmaceuticals, LLC5c60df47-58cf-5226-e053-2a91aa0a16462017-10-25Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cleansing WipesSALICYLIC ACIDNextcell Medicale0ad155f-8afb-42ba-a2c3-c10f275612012017-07-28WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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