FDA.reportPublic FDA data

Listerine Cool Mint Antiseptic

Product NDC
69968-0550
11-digit product format
699680550
Labeler code
69968
Product ID
69968-0550_22799002-2553-5bc1-e063-6394a90a8fa0
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, and Thymol
Dosage form
LIQUID
Route
ORAL
Labeler
Kenvue Brands LLC
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

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 Identifiers#

Field, Values table
FieldValues
UniiRV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui1043619, 1043623

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
69968-0550-1Listerine Cool Mint Antiseptic946.353 mL in 1 BOTTLELIQUID946.35311
69968-0550-2Listerine Cool Mint Antiseptic250 mL in 1 BOTTLELIQUID25011
69968-0550-3Listerine Cool Mint Antiseptic3700 mL in 1 BOTTLELIQUID370011
69968-0550-4Listerine Cool Mint Antiseptic1419.529 mL in 1 BOTTLELIQUID1419.52911
69968-0550-5Listerine Cool Mint Antiseptic500 mL in 1 BOTTLELIQUID50011
69968-0550-8Listerine Cool Mint Antiseptic2 in 1 PACKAGELIQUID211
69968-0550-9Listerine Cool Mint Antiseptic95 mL in 1 BOTTLELIQUID9511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0550LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) LIQUID [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 7 package rows20241114_9e97e4f8-80c2-44e0-862c-0dfca392a436.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN9e97e4f8-80c2-44e0-862c-0dfca392a43611
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN9e97e4f8-80c2-44e0-862c-0dfca392a43611
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD9e97e4f8-80c2-44e0-862c-0dfca392a43611
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD9e97e4f8-80c2-44e0-862c-0dfca392a43611
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY9e97e4f8-80c2-44e0-862c-0dfca392a43611
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY9e97e4f8-80c2-44e0-862c-0dfca392a43611
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 startMarketing endSampleExclude flagStatus
69968-0550-169968055001946.353 mL in 1 BOTTLE (69968-0550-1) 946.353 ml2018-12-030000-00-00NoNoCurrent
69968-0550-269968055002250 mL in 1 BOTTLE (69968-0550-2) 250 ml2018-12-030000-00-00NoNoCurrent
69968-0550-3699680550033700 mL in 1 BOTTLE (69968-0550-3) 3700 ml2019-01-010000-00-00NoNoCurrent
69968-0550-4699680550041419.529 mL in 1 BOTTLE (69968-0550-4) 1419.529 ml2018-12-030000-00-00NoNoCurrent
69968-0550-569968055005500 mL in 1 BOTTLE (69968-0550-5) 500 ml2018-12-030000-00-00NoNoCurrent
69968-0550-8699680550082 BOTTLE in 1 PACKAGE (69968-0550-8) / 1419.529 mL in 1 BOTTLE (69968-0550-4) 2 bottle2020-11-240000-00-00NoNoCurrent
69968-0550-96996805500995 mL in 1 BOTTLE (69968-0550-9) 95 ml2018-12-030000-00-00NoNoCurrent