Listerine SmartRinse Anticavity Fluoride Rinse

Product NDC
42002-618
11-digit product format
420020618
Labeler code
42002
Product ID
42002-618_0155240d-6927-4cff-a620-c574616f9a2a
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
2014-05-12
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct42002-618DDiscontinued by firm2026-10-05
excluded packagepackage42002-61842002-618-72DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-618-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-618-72f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-618-722ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-618-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-618-72cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-618-72cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-618-72302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-618-72ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-618-720efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42002-618-72ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42002-618-72367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42002-618-72557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
Fluoride IonACTIVE MOIETYQ80VPU408OLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
Cetylpyridinium ChlorideINACTIVE INGREDIENTD9OM4SK49PLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RLISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]2