FDA.reportPublic FDA data

Listerine Gum Therapy Mouthwash Glacier Mint

Product NDC
69968-0948
11-digit product format
699680948
Labeler code
69968
Product ID
69968-0948_40a0be97-d2ba-fd06-e063-6394a90a76ad
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
2025-10-15
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 Gum Therapy Mouthwash Glacier Mint
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
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0948-1Listerine Gum Therapy Mouthwash Glacier Mint1000 mL in 1 BOTTLEMOUTHWASH10001
69968-0948-5Listerine Gum Therapy Mouthwash Glacier Mint500 mL in 1 BOTTLEMOUTHWASH5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN40a0bdf3-1698-1449-e063-6394a90ab13d1
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN40a0bdf3-1698-1449-e063-6394a90ab13d1
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD40a0bdf3-1698-1449-e063-6394a90ab13d1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD40a0bdf3-1698-1449-e063-6394a90ab13d1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY40a0bdf3-1698-1449-e063-6394a90ab13d1
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY40a0bdf3-1698-1449-e063-6394a90ab13d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0948-1699680948011000 mL in 1 BOTTLE (69968-0948-1) 1000 ml2025-10-15NoNoCurrent
69968-0948-569968094805500 mL in 1 BOTTLE (69968-0948-5) 500 ml2025-10-15NoNoCurrent