FDA.reportPublic FDA data

Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash

Product NDC
69968-0904
11-digit product format
699680904
Labeler code
69968
Product ID
69968-0904_4599a1af-50b0-9a26-e063-6294a90ad25d
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
2024-12-11
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 Total Care Kids Anticavity Fluoride 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0904-3Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash27 mL in 1 BOTTLEMOUTHWASH272
69968-0904-5Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash500 mL in 1 BOTTLEMOUTHWASH5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0904LISTERINE TOTAL CARE KIDS ANTICAVITY FLUORIDE RINSE - BERRY SPLASH (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]1Current NDC, 2 package rows20241211_28986d7f-3e9a-8dfb-e063-6394a90a731e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN28986d7f-3e9a-8dfb-e063-6394a90a731e2
313029sodium fluoride 0.2 MG/ML MouthwashSCD28986d7f-3e9a-8dfb-e063-6394a90a731e2
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY28986d7f-3e9a-8dfb-e063-6394a90a731e2
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY28986d7f-3e9a-8dfb-e063-6394a90a731e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0904-36996809040327 mL in 1 BOTTLE (69968-0904-3) 27 ml2025-12-19NoNoHistorical
69968-0904-569968090405500 mL in 1 BOTTLE (69968-0904-5) 500 ml2024-12-11NoNoHistorical