FDA.reportPublic FDA data

LISTERINE

Product NDC
69968-0400
11-digit product format
699680400
Labeler code
69968
Product ID
69968-0400_2f2db917-d08b-0560-e063-6394a90aba42
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, and Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-06
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
Brand name suffix
Original 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
69968-0400-1LISTERINEOriginal Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150011
69968-0400-2LISTERINEOriginal Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25011
69968-0400-3LISTERINEOriginal Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100011
69968-0400-5LISTERINEOriginal Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50011
69968-0400-8LISTERINEOriginal Antiseptic2 in 1 PACKAGEMOUTHWASH211
69968-0400-9LISTERINEOriginal Antiseptic95 mL in 1 BOTTLE, PLASTICMOUTHWASH9511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0400LISTERINE ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 6 package rows20250308_78e2e172-09a4-4bf1-9871-d099c49087be.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 % MouthwashPSN78e2e172-09a4-4bf1-9871-d099c49087be11
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN78e2e172-09a4-4bf1-9871-d099c49087be11
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD78e2e172-09a4-4bf1-9871-d099c49087be11
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD78e2e172-09a4-4bf1-9871-d099c49087be11
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY78e2e172-09a4-4bf1-9871-d099c49087be11
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY78e2e172-09a4-4bf1-9871-d099c49087be11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0400-1699680400011500 mL in 1 BOTTLE, PLASTIC (69968-0400-1) 1500 ml2019-01-060000-00-00NoNoCurrent
69968-0400-269968040002250 mL in 1 BOTTLE, PLASTIC (69968-0400-2) 250 ml2019-01-060000-00-00NoNoCurrent
69968-0400-3699680400031000 mL in 1 BOTTLE, PLASTIC (69968-0400-3) 1000 ml2019-01-060000-00-00NoNoCurrent
69968-0400-569968040005500 mL in 1 BOTTLE, PLASTIC (69968-0400-5) 500 ml2019-01-060000-00-00NoNoCurrent
69968-0400-8699680400082 BOTTLE, PLASTIC in 1 PACKAGE (69968-0400-8) / 1500 mL in 1 BOTTLE, PLASTIC (69968-0400-1) 2019-01-060000-00-00NoNoCurrent
69968-0400-96996804000995 mL in 1 BOTTLE, PLASTIC (69968-0400-9) 95 ml2019-01-060000-00-00NoNoCurrent