FDA.reportPublic FDA data

Listerine FreshBurst Antiseptic

Product NDC
69968-0239
11-digit product format
699680239
Labeler code
69968
Product ID
69968-0239_22634de5-9318-1b56-e063-6394a90a6245
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
2018-08-17
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 FreshBurst 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
69968-0239-1Listerine FreshBurst Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009
69968-0239-2Listerine FreshBurst Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH2509
69968-0239-3Listerine FreshBurst Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15009
69968-0239-5Listerine FreshBurst Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5009
69968-0239-8Listerine FreshBurst Antiseptic2 in 1 PACKAGEMOUTHWASH29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0239LISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 5 package rows20241114_62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8.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 % MouthwashPSN62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY62b5c3ee-01cc-4c4e-9f28-e7dafa7372d89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0239-1699680239011000 mL in 1 BOTTLE, PLASTIC (69968-0239-1) 1000 ml2018-09-180000-00-00NoNoCurrent
69968-0239-269968023902250 mL in 1 BOTTLE, PLASTIC (69968-0239-2) 250 ml2019-05-030000-00-00NoNoCurrent
69968-0239-3699680239031500 mL in 1 BOTTLE, PLASTIC (69968-0239-3) 1500 ml2018-08-280000-00-00NoNoCurrent
69968-0239-569968023905500 mL in 1 BOTTLE, PLASTIC (69968-0239-5) 500 ml2018-08-170000-00-00NoNoCurrent
69968-0239-8699680239082 BOTTLE, PLASTIC in 1 PACKAGE (69968-0239-8) > 1500 mL in 1 BOTTLE, PLASTIC (69968-0239-3) 2020-04-240000-00-00NoNoCurrent