Western Family Whitening Plus Minty Fresh Mouthwash Anticavity

Product NDC
55312-182
11-digit product format
553120182
Labeler code
55312
Product ID
55312-182_7f6d7336-dcd2-43d1-a252-8d778d2f320b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Western Family Foods, Inc
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-11-24
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
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 productproduct55312-182IInactivated by FDA2026-10-05
excluded packagepackage55312-18255312-182-05IInactivated by FDA2026-10-05

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 · 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 packagepackage55312-182-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-182-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-182-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-182-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-182-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-182-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-182-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-182-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-182-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-182-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-182-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-182-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55312-182-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55312-182-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55312-182-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55312-182-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55312-182-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55312-182-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55312-182-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55312-182-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55312-182-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55312-182-05110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-182-052019-10-29C16284748780-1960f7f55-cc7d-8e05-e053-dbdaa90a074aWestern Family Whitening Plus Minty Fresh Mouthwash Fluoride Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-182-05Western Family Whitening Plus Minty Fresh Mouthwash Anticavity181.4 g in 1 TUBEPASTE, DENTIFRICE181.42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
Fluoride IonACTIVE MOIETYQ80VPU408OWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
TRICLOSANINACTIVE INGREDIENT4NM5039Y5XWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEWESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-182WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]2Legacy NDC, 1 package rows20110222_651124ba-d5c4-415c-9d7b-6642c9fbcb55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN651124ba-d5c4-415c-9d7b-6642c9fbcb552
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD651124ba-d5c4-415c-9d7b-6642c9fbcb552
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY651124ba-d5c4-415c-9d7b-6642c9fbcb552
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY651124ba-d5c4-415c-9d7b-6642c9fbcb552
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY651124ba-d5c4-415c-9d7b-6642c9fbcb552
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY651124ba-d5c4-415c-9d7b-6642c9fbcb552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-182-0555312018205181.4 g in 1 TUBE181.4 gHistorical