Listerine HealthyWhite Restoring Clean Mint

Product NDC
42002-512
11-digit product format
420020512
Labeler code
42002
Product ID
42002-512_4db29659-eaa4-49fc-a7c0-da73d6c4be55
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
2010-01-01
Marketing end
2021-05-13
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42002-512DDiscontinued by firm2026-10-05
excluded packagepackage42002-51242002-512-16DDiscontinued by firm2026-10-05
excluded packagepackage42002-51242002-512-32DDiscontinued 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 · 36 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 packagepackage42002-512-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-512-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-512-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-512-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-512-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-512-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-512-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-512-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-512-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-512-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-512-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-512-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-512-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-512-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-512-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-512-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-512-320efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-512-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42002-512-32ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42002-512-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42002-512-32367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42002-512-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42002-512-32557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42002-512-16557ba5c1ecfa…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 HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Hydrogen PeroxideINACTIVE INGREDIENTBBX060AN9VLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2LISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Polyoxyl 40 Hydrogenated Castor OilINACTIVE INGREDIENT7YC686GQ8FLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4LISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RLISTERINE HEALTHYWHITE RESTORING CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42002-512-1642002051216473 mL in 1 BOTTLE (42002-512-16) 473 ml2010-01-012021-05-13NoNoCurrent