FDA.reportPublic FDA data

Listerine Smart Rinse Berry Splash

Product NDC
69968-0606
11-digit product format
699680606
Labeler code
69968
Product ID
69968-0606_21be25b1-b487-3c76-e063-6394a90ac748
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-06
Substance
SODIUM FLUORIDE
Active strength
.1 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 Smart Rinse Berry Splash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1798474

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0606-3Listerine Smart Rinse Berry Splash27 mL in 1 BOTTLE, DISPENSINGMOUTHWASH276
69968-0606-5Listerine Smart Rinse Berry Splash500 mL in 1 BOTTLE, DISPENSINGMOUTHWASH5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0606LISTERINE SMART RINSE BERRY SPLASH (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 2 package rows20241114_5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
313029sodium fluoride 0.2 MG/ML MouthwashSCD5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
1798474Listerine 0.2 MG/ML MouthwashSY5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0606-36996806060327 mL in 1 BOTTLE, DISPENSING (69968-0606-3) 27 ml2020-01-060000-00-00NoNoCurrent
69968-0606-569968060605500 mL in 1 BOTTLE, DISPENSING (69968-0606-5) 500 ml2020-01-060000-00-00NoNoCurrent