FDA.reportPublic FDA data

Listerine Gum Therapy

Product NDC
69968-0790
11-digit product format
699680790
Labeler code
69968
Product ID
69968-0790_224a6178-002f-bc85-e063-6394a90a5879
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
2023-02-13
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
Brand name suffix
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0790-1Listerine Gum TherapyGlacier Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10006
69968-0790-2Listerine Gum TherapyGlacier Mint1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15006
69968-0790-3Listerine Gum TherapyGlacier Mint2 in 1 TRAYMOUTHWASH26
69968-0790-3Listerine Gum TherapyGlacier Mint1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15006
69968-0790-5Listerine Gum TherapyGlacier Mint500 mL in 1 BOTTLE, PLASTICMOUTHWASH5006
69968-0790-9Listerine Gum TherapyGlacier Mint95 mL in 1 BOTTLE, PLASTICMOUTHWASH956

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0790LISTERINE GUM THERAPY GLACIER MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, 6 package rows20241114_ed6889b6-58db-41cf-e053-2a95a90a7de2.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 % MouthwashPSNed6889b6-58db-41cf-e053-2a95a90a7de26
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDed6889b6-58db-41cf-e053-2a95a90a7de26
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYed6889b6-58db-41cf-e053-2a95a90a7de26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0790-1699680790011000 mL in 1 BOTTLE, PLASTIC (69968-0790-1) 1000 ml2023-02-13NoNoHistorical
69968-0790-2699680790021500 mL in 1 BOTTLE, PLASTIC (69968-0790-2) 1500 ml2023-12-01NoNoHistorical
69968-0790-3699680790032 BOTTLE, PLASTIC in 1 TRAY (69968-0790-3) / 1500 mL in 1 BOTTLE, PLASTIC2024-03-01NoNoHistorical
69968-0790-569968079005500 mL in 1 BOTTLE, PLASTIC (69968-0790-5) 500 ml2023-02-13NoNoHistorical
69968-0790-96996807900995 mL in 1 BOTTLE, PLASTIC (69968-0790-9) 95 ml2023-02-13NoNoHistorical