FDA.reportPublic FDA data

Listerine Cool Mint Antiseptic

Product NDC
67751-216
11-digit product format
677510216
Labeler code
67751
Product ID
67751-216_23956e55-6b5a-095b-e063-6394a90a6f1d
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, and Thymol
Dosage form
LIQUID
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-03
Substance
EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; 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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal 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
f5f26e2f-8a1f-4687-e053-2a95a90ae378Available 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
67751-216-01Listerine Cool Mint Antiseptic1 in 1 BLISTER PACKLIQUID12
67751-216-01Listerine Cool Mint Antiseptic95 mL in 1 BOTTLELIQUID952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-216LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) LIQUID [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 2 package rows20241004_f5f26e2f-8a1f-4687-e053-2a95a90ae378.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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
application number: M022
Bubble Gum Flavor For Kids 25g 50gBUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50GWORLD DENTISTS ASSOCIATION AMERICA LIMITED354c1eda-ec5b-a8c7-e063-6294a90a871d2025-05-16WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDESafeway, Inc.8fe2f1df-3264-455d-b62c-953dce171c022025-05-16WarningsExact identifier
application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
application number: M022
Parodontax Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
application number: M022
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEStrategic Sourcing Services LLC5260258a-bb1e-43d6-bce1-70a38778a64a2025-04-14WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDETARGET Corporation93d0bb3a-51d3-44c8-8fb7-bdb82adfbb652025-04-14WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
application number: M022
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
application number: M022
Sensodyne Complete Protection Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLCe3cc3146-8aed-4f6b-a252-e379418c2b8d2025-03-26WarningsExact identifier
application number: M022
Listerine Freshburst AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee1e1df9-74c6-d24b-e053-2a95a90a43d32025-03-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEGood Sense (Geiss, Destin & Dunn, Inc.)cfe9be26-e4a4-413c-a602-2f5948e3bb7a2025-03-03WarningsExact identifier
application number: M022
LISTERINE Original AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC78e2e172-09a4-4bf1-9871-d099c49087be2025-02-28WarningsExact identifier
application number: M022
WHITE GLO CHARCOAL SENSITIVEPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa5edb7fd-c637-5447-e053-2995a90a5a6f2025-02-26WarningsExact identifier
application number: M022
Glorysmile Toothpaste.GLORYSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd2ef48156-904d-e42a-e063-6394a90a3cd02025-02-25WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWalgreensc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa2025-02-21WarningsExact identifier
application number: M022
Sheffield Pain ReliefBENZOCAINESheffield Pharmaceuticals LLCe21abfdd-373d-42af-9535-fe1571382a652025-02-19WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWhole Foods Marketa2bb142e-8cbe-481e-bf4f-810ca6d145912025-02-12WarningsExact 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 % MouthwashPSNf5f26e2f-8a1f-4687-e053-2a95a90ae3782
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSNf5f26e2f-8a1f-4687-e053-2a95a90ae3782
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBDf5f26e2f-8a1f-4687-e053-2a95a90ae3782
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDf5f26e2f-8a1f-4687-e053-2a95a90ae3782
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYf5f26e2f-8a1f-4687-e053-2a95a90ae3782
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSYf5f26e2f-8a1f-4687-e053-2a95a90ae3782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67751-216-01677510216011 BOTTLE in 1 BLISTER PACK (67751-216-01) / 95 mL in 1 BOTTLE1 bottle2023-03-02NoNoCurrent