FDA.reportPublic FDA data

Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor

Product NDC
69968-0691
11-digit product format
699680691
Labeler code
69968
Product ID
69968-0691_ef22fd2b-e36a-8406-e053-2995a90ad7fe
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Johnson & Johnson Consumer Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69968-0691DDiscontinued by firm2026-10-12
excluded packagepackage69968-069169968-0691-5DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

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
69968-0691-5Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor500 mL in 1 BOTTLEMOUTHWASH5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0691LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - PINK LEMONADE FLAVOR (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]4Legacy NDC, 1 package rows20241114_773255d9-aa0c-435e-a1e5-0b9332793831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN773255d9-aa0c-435e-a1e5-0b93327938315
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN773255d9-aa0c-435e-a1e5-0b93327938315
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD773255d9-aa0c-435e-a1e5-0b93327938315
313029sodium fluoride 0.2 MG/ML MouthwashSCD773255d9-aa0c-435e-a1e5-0b93327938315
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY773255d9-aa0c-435e-a1e5-0b93327938315
1798474Listerine 0.2 MG/ML MouthwashSY773255d9-aa0c-435e-a1e5-0b93327938315
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY773255d9-aa0c-435e-a1e5-0b93327938315
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY773255d9-aa0c-435e-a1e5-0b93327938315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0691-569968069105500 mL in 1 BOTTLE (69968-0691-5) 500 ml2021-01-010000-00-00NoNoCurrent