Home NDC 51009-158 Whole Care
Product NDC 51009-158
11-digit product format 510090158
Labeler code 51009
Product ID 51009-158_c7333209-327b-461e-b401-4e317f78aeec
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Tom's of Maine, Inc.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-02-14
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 0 g/g
NDC exclude flag No
Listing certified through 2023-12-31
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 · 32 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 51009-158-47 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 51009-158-47 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51009-158-47 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 51009-158-47 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 51009-158-47 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 51009-158-47 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 51009-158-47 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
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 Sodium fluoride ACTIVE INGREDIENT 8ZYQ1474W7 WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Fluoride ion ACTIVE MOIETY Q80VPU408O WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Hydrated Silica INACTIVE INGREDIENT Y6O7T4G8P9 WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Mango INACTIVE INGREDIENT I629I3NR86 WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Orange Oil INACTIVE INGREDIENT AKN3KSD11B WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Peppermint oil INACTIVE INGREDIENT AV092KU4JH WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Spearmint Oil INACTIVE INGREDIENT C3M81465G5 WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Xanthan gum INACTIVE INGREDIENT TTV12P4NEE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Xylitol INACTIVE INGREDIENT VCQ006KQ1E WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2 Zinc citrate INACTIVE INGREDIENT K72I3DEX9B WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51009-158-47 51009015847 1 TUBE in 1 CARTON (51009-158-47) > 133 g in 1 TUBE 1 tube 2011-02-14 0000-00-00 No No Current