FDA.reportPublic FDA data

Listerine Ultraclean Antiseptic

Product NDC
69968-0539
11-digit product format
699680539
Labeler code
69968
Product ID
69968-0539_22797442-320d-5c9c-e063-6394a90a20c8
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
2012-06-01
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 Ultraclean Antiseptic
Brand name suffix
Cool 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, 2043303

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
69968-0539-1Listerine Ultraclean AntisepticCool Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100010
69968-0539-2Listerine Ultraclean AntisepticCool Mint250 mL in 1 BOTTLE, PLASTICMOUTHWASH25010
69968-0539-3Listerine Ultraclean AntisepticCool Mint1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150010
69968-0539-4Listerine Ultraclean AntisepticCool Mint2 in 1 PACKAGEMOUTHWASH210
69968-0539-5Listerine Ultraclean AntisepticCool Mint500 mL in 1 BOTTLE, PLASTICMOUTHWASH50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0539LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 5 package rows20241114_dd3729c2-fd05-4db0-a542-487bb0f9001f.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 % MouthwashPSNdd3729c2-fd05-4db0-a542-487bb0f9001f10
2043303LISTERINE ULTRACLEAN 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSNdd3729c2-fd05-4db0-a542-487bb0f9001f10
2043303eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Ultraclean]SBDdd3729c2-fd05-4db0-a542-487bb0f9001f10
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDdd3729c2-fd05-4db0-a542-487bb0f9001f10
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYdd3729c2-fd05-4db0-a542-487bb0f9001f10
2043303Listerine Ultraclean (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSYdd3729c2-fd05-4db0-a542-487bb0f9001f10
2043303Listerine Ultraclean Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSYdd3729c2-fd05-4db0-a542-487bb0f9001f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0539-1699680539011000 mL in 1 BOTTLE, PLASTIC (69968-0539-1) 1000 ml2012-06-010000-00-00NoNoCurrent
69968-0539-269968053902250 mL in 1 BOTTLE, PLASTIC (69968-0539-2) 250 ml2012-06-010000-00-00NoNoCurrent
69968-0539-3699680539031500 mL in 1 BOTTLE, PLASTIC (69968-0539-3) 1500 ml2012-06-010000-00-00NoNoCurrent
69968-0539-4699680539042 BOTTLE, PLASTIC in 1 PACKAGE (69968-0539-4) / 1500 mL in 1 BOTTLE, PLASTIC (69968-0539-3) 2012-06-010000-00-00NoNoCurrent
69968-0539-569968053905500 mL in 1 BOTTLE, PLASTIC (69968-0539-5) 500 ml2012-06-010000-00-00NoNoCurrent