Toms Natural Fluoride-free Strength Sensitive Wintermint

Product NDC
51009-214
11-digit product format
510090214
Labeler code
51009
Product ID
51009-214_be324274-e18f-43f9-b57c-e35a11747518
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-05-01
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE
Active strength
0 g/g
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 productproduct51009-214DDiscontinued by firm2026-08-17
excluded packagepackage51009-21451009-214-40DDiscontinued by firm2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51009-214-40DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51009-214-40DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51009-214-40DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51009-214-40DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51009-214-40DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51009-214-40DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51009-214-40DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51009-214-40DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51009-214-40DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51009-214-40IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51009-214-40IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51009-214-40IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51009-214-40IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51009-214-40IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51009-214-40IInactivated by FDA1332a3947898…d4bfe170f9cd…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium NitrateACTIVE INGREDIENTRU45X2JN0ZTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Nitrate IonACTIVE MOIETYT93E9Y2844TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEETOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ETOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-214-40510090214401 TUBE in 1 CARTON (51009-214-40) > 113 g in 1 TUBE1 tube2015-05-010000-00-00NoNoCurrent