Home NDC 51009-213-40 Toms Natural Maximum Strength Sensitive Soothing Mint
Product NDC 51009-213
Requested package NDC 51009-213-40
11-digit product format 510090213
Labeler code 51009
Product ID 51009-213_7ffb81cb-bec2-40f5-b518-5fece58ad173
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate and Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Tom's of Maine, Inc.
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-03-01
Marketing end 0000-00-00
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 0 g/g; g/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Potassium Nitrate ACTIVE INGREDIENT RU45X2JN0Z TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Sodium fluoride ACTIVE INGREDIENT 8ZYQ1474W7 TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 fluoride ion ACTIVE MOIETY Q80VPU408O TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Nitrate Ion ACTIVE MOIETY T93E9Y2844 TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 cocamidopropyl betaine INACTIVE INGREDIENT 5OCF3O11KX TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Methyl Salicylate INACTIVE INGREDIENT LAV5U5022Y TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Xanthan gum INACTIVE INGREDIENT TTV12P4NEE TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Xylitol INACTIVE INGREDIENT VCQ006KQ1E TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51009-213-40 51009021340 1 TUBE in 1 CARTON (51009-213-40) > 113 g in 1 TUBE 1 tube 2015-03-01 0000-00-00 No No Current