FDA.reportPublic FDA data

Listerine Cool Mint Antiseptic

Product NDC
69968-0791
11-digit product format
699680791
Labeler code
69968
Product ID
69968-0791_2f7de032-dffb-089c-e063-6394a90a673a
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-21
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Listerine Cool Mint Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup
1043623Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
edb9e374-4dba-5823-e053-2a95a90a3da5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

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 1 of 42 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNedb9e374-4dba-5823-e053-2a95a90a3da57
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSNedb9e374-4dba-5823-e053-2a95a90a3da57
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBDedb9e374-4dba-5823-e053-2a95a90a3da57
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDedb9e374-4dba-5823-e053-2a95a90a3da57
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYedb9e374-4dba-5823-e053-2a95a90a3da57
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSYedb9e374-4dba-5823-e053-2a95a90a3da57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0791-1699680791011000 mL in 1 BOTTLE, PLASTIC (69968-0791-1) 1000 ml2023-03-21NoNoCurrent
69968-0791-2699680791021500 mL in 1 BOTTLE, PLASTIC (69968-0791-2) 1500 ml2023-03-21NoNoCurrent
69968-0791-369968079103250 mL in 1 BOTTLE, PLASTIC (69968-0791-3) 250 ml2023-03-21NoNoCurrent
69968-0791-4699680791043700 mL in 1 BOTTLE, PLASTIC (69968-0791-4) 3700 ml2023-03-21NoNoCurrent
69968-0791-569968079105500 mL in 1 BOTTLE, PLASTIC (69968-0791-5) 500 ml2023-03-21NoNoCurrent
69968-0791-6699680791062 BOTTLE, PLASTIC in 1 PACKAGE (69968-0791-6) / 1500 mL in 1 BOTTLE, PLASTIC2023-03-21NoNoCurrent
69968-0791-96996807910995 mL in 1 BOTTLE, PLASTIC (69968-0791-9) 95 ml2023-03-21NoNoCurrent