Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula

Product NDC
42288-000
11-digit product format
422880000
Labeler code
42288
Product ID
42288-000_d6ce07ce-edee-46ee-93d1-bb4411373b7f
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
SLH Optimal Health LLC
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-03
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42288-000IInactivated by FDA2026-08-11
excluded packagepackage42288-00042288-000-04IInactivated by FDA2026-08-11

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 · 44 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 packagepackage42288-000-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42288-000-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42288-000-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42288-000-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42288-000-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42288-000-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42288-000-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42288-000-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42288-000-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42288-000-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42288-000-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42288-000-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42288-000-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42288-000-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42288-000-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42288-000-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42288-000-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42288-000-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42288-000-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42288-000-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42288-000-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42288-000-04110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42288-000-042019-11-27C16284748780-19855d018-d5ef-cd31-e053-dbdaa90ab51aSpearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42288-000-04Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula Gentle Formula116 g in 1 TUBEPASTE, DENTIFRICE1164

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
BIXA ORELLANA SEEDINACTIVE INGREDIENTO87354RZ5ASPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RSPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42288-000SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA (SODIUM FLUORIDE) PASTE, DENTIFRICE [SLH OPTIMAL HEALTH LLC]4Legacy NDC, 1 package rows20121005_e2d6607c-a33b-442f-8fb1-5ed5232f258d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNe2d6607c-a33b-442f-8fb1-5ed5232f258d4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDe2d6607c-a33b-442f-8fb1-5ed5232f258d4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYe2d6607c-a33b-442f-8fb1-5ed5232f258d4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe2d6607c-a33b-442f-8fb1-5ed5232f258d4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe2d6607c-a33b-442f-8fb1-5ed5232f258d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42288-000-0442288000004116 g in 1 TUBE116 gHistorical