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 43 of 302 · 6,032 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
unii: L7T10EIP3A
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
unii: L7T10EIP3A
Plantar Pain Relief PatchLIDOCAINE AND MENTHOLGuangzhou Sumi Technology Innovation Co., Ltd4e8734db-e474-e1fa-e063-6394a90a30292026-05-14WarningsExact identifier
unii: L7T10EIP3A
Hand SanALCOHOLRochester Midland Corporation2d89982d-d1fd-4a98-8b44-c2ae3545be582026-05-14WarningsExact identifier
unii: 3K9958V90M
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
unii: L7T10EIP3A
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Pain ReliefLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3ed51136-ea8e-8101-e063-6394a90acd4c2026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.4fdae0ab-94ba-5707-e063-6294a90a1f9d2026-05-14WarningsExact identifier
unii: L7T10EIP3A
OVERNIGHT RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.2c6c4737-dff3-6382-e063-6294a90a412c2026-05-14WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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