FDA.reportPublic FDA data

Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash

Product NDC
69968-0959
11-digit product format
699680959
Labeler code
69968
Product ID
69968-0959_49d289a5-76d4-9189-e063-6294a90a6093
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
2026-02-13
Substance
METHYL SALICYLATE; THYMOL; EUCALYPTOL; MENTHOL
Active strength
.6; .64; .92; .42 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup
2043303Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
49d28991-b68f-ba16-e063-6394a90a0b13Available on FDA.report

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
69968-0959-1Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash1000 mL in 1 BOTTLEMOUTHWASH10001
69968-0959-2Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash1500 mL in 1 BOTTLEMOUTHWASH15001
69968-0959-5Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash500 mL in 1 BOTTLEMOUTHWASH5001

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN49d28991-b68f-ba16-e063-6394a90a0b131
2043303LISTERINE ULTRACLEAN 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN49d28991-b68f-ba16-e063-6394a90a0b131
2043303eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Ultraclean]SBD49d28991-b68f-ba16-e063-6394a90a0b131
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD49d28991-b68f-ba16-e063-6394a90a0b131
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY49d28991-b68f-ba16-e063-6394a90a0b131
2043303Listerine Ultraclean (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY49d28991-b68f-ba16-e063-6394a90a0b131
2043303Listerine Ultraclean Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY49d28991-b68f-ba16-e063-6394a90a0b131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0959-1699680959011000 mL in 1 BOTTLE (69968-0959-1) 1000 ml2026-02-13NoNoCurrent
69968-0959-2699680959021500 mL in 1 BOTTLE (69968-0959-2) 1500 ml2026-02-13NoNoCurrent
69968-0959-569968095905500 mL in 1 BOTTLE (69968-0959-5) 500 ml2026-02-13NoNoCurrent