FDA.reportPublic FDA data

NDC 69968-0791-01 - Listerine Cool Mint Antiseptic

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
69968-0791
Requested NDC
69968-0791-01
Package NDCs from labels
69968-0791-1, 69968-0791-9, 69968-0791-3, 69968-0791-2, 69968-0791-4, 69968-0791-5, 69968-0791-6, 69968-0791-01
Manufacturer
Kenvue Brands LLC
Effective date
2025-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Listerine Cool Mint Antiseptic - Kenvue Brands LLCKenvue Brands LLC2025-03-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0791-1Listerine Cool Mint Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007
69968-0791-2Listerine Cool Mint Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15007
69968-0791-3Listerine Cool Mint Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH2507
69968-0791-4Listerine Cool Mint Antiseptic3700 mL in 1 BOTTLE, PLASTICMOUTHWASH37007
69968-0791-5Listerine Cool Mint Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5007
69968-0791-6Listerine Cool Mint Antiseptic2 in 1 PACKAGEMOUTHWASH27
69968-0791-6Listerine Cool Mint Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15007
69968-0791-9Listerine Cool Mint Antiseptic95 mL in 1 BOTTLE, PLASTICMOUTHWASH957

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0791LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC]7Current NDC, 8 package rows20250308_edb9e374-4dba-5823-e053-2a95a90a3da5.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 11 of 304 · 6,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3fea32bb-98ec-4dc6-97d3-c77d8e476c042026-08-13WarningsExact identifier
unii: 3K9958V90M
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
unii: L7T10EIP3A
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
unii: L7T10EIP3A
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
unii: L7T10EIP3A
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
unii: L7T10EIP3A
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-08-12WarningsExact identifier
unii: 3K9958V90M
ZoviroALCOHOLZoviro, LLC9c8ca084-8aef-4616-8d51-aaff3eb253432026-08-12WarningsExact identifier
unii: 3K9958V90M
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
1ST MEDXPATCH WITH LIDOCAINE 4%-RXLIDOCAINE, CAPSAICIN, MENTHOL, METHYL SALICYLATE1ST MEDX LLCb55585cf-45da-4b78-b68e-f7dddf23bfe72026-08-11WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: 8SKN0B0MIM
RenapathBENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, DNA, EUPATORIUM PURPUREUM, GLANDULA SUPRARENALIS SUIS, HYDRANGEA ARBORESCENS, HYPOTHALAMUS, MERCURIUS CORROSIVUS, PANCREAS SUIS, PAREIRA BRAVA, PETROSELINUM SATIVUM, PITUITARUM POSTERIUM, RUBIA TINCTORUM, SARSAPARILLA, SOLIDAGO VIRGAUREA, THYROIDINUM (BOVINE), UVA-URSIEnergetix Corporation1a37b994-9470-4266-a4e1-008538ea0edf2026-08-11WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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