Home NDC 51009-197 Sensitive
Product NDC 51009-197
11-digit product format 510090197
Labeler code 51009
Product ID 51009-197_88025f94-dded-4b7e-b60e-a05d15fea617
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 2009-09-01
Marketing end 0000-00-00
Substance POTASSIUM NITRATE
Active strength 0 g/g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51009-197-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51009-197-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51009-197-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51009-197-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51009-197-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51009-197-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51009-197-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51009-197-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51009-197-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 51009-197-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 51009-197-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51009-197-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51009-197-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51009-197-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51009-197-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 51009-197-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 51009-197-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 51009-197-04 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 51009-197-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
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 SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Potassium Cation ACTIVE MOIETY 295O53K152 SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 cocamidopropyl betaine INACTIVE INGREDIENT 5OCF3O11KX SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 glycyrrhizin INACTIVE INGREDIENT 6FO62043WK SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 hydrated silica INACTIVE INGREDIENT Y6O7T4G8P9 SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 menthol INACTIVE INGREDIENT L7T10EIP3A SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 xanthan gum INACTIVE INGREDIENT TTV12P4NEE SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 xylitol INACTIVE INGREDIENT VCQ006KQ1E SENSITIVE FLUORIDE-FREE - WINTERMINT (POTASSIUM NITRATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1