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 99 of 300 · 5,999 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
unii: L7T10EIP3A
Smart Care CALMING LAVENDER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.88d45355-3578-42bf-8c22-3efcbb99e59a2026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care tokidoki Mermicorno SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.529d13e4-f6b7-4c7a-bb62-094f845b94282026-01-13WarningsExact identifier
unii: 3K9958V90M
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
unii: L7T10EIP3A
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
application number: M022
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.062fc0fd-a501-411c-baff-0ad4c23cae3e2026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care LEMON LIME HAND SANITIZERETHYL ALCOHOLAshtel Studios, Ince503895d-7b23-4865-90b3-5348faffd45c2026-01-13WarningsExact identifier
unii: 3K9958V90M
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
unii: L7T10EIP3A
Instant Hand SanitizerALCOHOLHydrox Laboratoriesa818def4-f6e9-4a97-aa26-b7c082ae8d182026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHydrox Laboratories285505b0-ee49-4d01-9019-1052e2fb19642026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer UnscentedALCOHOLHydrox Laboratoriescd42da2c-0235-4410-945b-baabb5c7931b2026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLLTC Products Inc.6c16aeec-bef2-41f1-b22d-ac37c36255622026-01-12WarningsExact identifier
unii: 3K9958V90M
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
unii: L7T10EIP3A
Hand Essentials Instant Hand AntisepticETHYL ALCOHOLHu-Friedy Mfg. Co., Inc.a580ebfb-2da9-4a20-9a3c-6244dbb7aef12026-01-12WarningsExact identifier
unii: 3K9958V90M
Epi-Clenz Pure Instant Hand AntisepticETHYL ALCOHOLMedline Industries, LP9f2be060-0699-47ab-9398-efe91eef22672026-01-12WarningsExact identifier
unii: 3K9958V90M
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
unii: L7T10EIP3A
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
unii: L7T10EIP3A
PURELL Advanced Hand Sanitizer be PeacefulALCOHOLGOJO Industries, Inc.45810c51-8738-4b8a-8d8f-46b4b41dbe932026-01-12WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer be VibrantALCOHOLGOJO Industries, Inc.3a991a7f-1289-4aeb-82f9-8cebd6a389b52026-01-12WarningsExact identifier
unii: 3K9958V90M
Purell Advanced RefreshingALCOHOLGOJO Industries, Inc.b1beadc4-5cf4-4e28-90cc-3f9fdc132a902026-01-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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