FDA.reportPublic FDA data

Toms Luminous White Fluoride Clean Mint

Product NDC
51009-218
11-digit product format
510090218
Labeler code
51009
Product ID
51009-218_7e71b02d-19bd-422f-b380-705a607b9823
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
2015-12-01
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51009-218DDiscontinued by firm2026-10-12
excluded packagepackage51009-21851009-218-21DDiscontinued by firm2026-10-12
excluded packagepackage51009-21851009-218-40DDiscontinued by firm2026-10-12
excluded packagepackage51009-21851009-218-75DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0551009-218-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0551009-218-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2651009-218-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2651009-218-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3151009-218-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3151009-218-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2851009-218-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2851009-218-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2151009-218-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2151009-218-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1051009-218-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1051009-218-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3151009-218-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3151009-218-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2051009-218-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2051009-218-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1051009-218-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1051009-218-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0851009-218-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0851009-218-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0351009-218-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0351009-218-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0951009-218-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0951009-218-75557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-218-21Toms Luminous White Fluoride Clean Mintcavity protection / whitening21 g in 1 TUBEPASTE, DENTIFRICE219
51009-218-40Toms Luminous White Fluoride Clean Mintcavity protection / whitening1 in 1 CARTONPASTE, DENTIFRICE19
51009-218-40Toms Luminous White Fluoride Clean Mintcavity protection / whitening113 g in 1 TUBEPASTE, DENTIFRICE1139
51009-218-75Toms Luminous White Fluoride Clean Mintcavity protection / whitening21 g in 1 TUBEPASTE, DENTIFRICE219
51009-218-75Toms Luminous White Fluoride Clean Mintcavity protection / whitening1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-218TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT CAVITY PROTECTION / WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]8Legacy NDC, 5 package rows20241024_7d0bc7be-da6e-4c24-9be9-8a0b40f27960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN7d0bc7be-da6e-4c24-9be9-8a0b40f279609
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD7d0bc7be-da6e-4c24-9be9-8a0b40f279609
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY7d0bc7be-da6e-4c24-9be9-8a0b40f279609
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY7d0bc7be-da6e-4c24-9be9-8a0b40f279609
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY7d0bc7be-da6e-4c24-9be9-8a0b40f279609
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY7d0bc7be-da6e-4c24-9be9-8a0b40f279609

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-218-215100902182121 g in 1 TUBE (51009-218-21) 21 g2018-07-250000-00-00NoNoCurrent
51009-218-40510090218401 TUBE in 1 CARTON (51009-218-40) > 113 g in 1 TUBE1 tube2018-11-130000-00-00NoNoCurrent
51009-218-47510090218471 TUBE in 1 CARTON (51009-218-47) > 133 g in 1 TUBE1 tube2015-12-010000-00-00NoNoCurrent
51009-218-75510090218751 TUBE in 1 CARTON (51009-218-75) > 21 g in 1 TUBE1 tube2017-10-200000-00-00NoNoCurrent