FDA.reportPublic FDA data

Toms Luminous White Fluoride Clean Mint

Product NDC
51009-218
Requested package NDC
51009-218-40
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 · 1 matching rows.

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

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
51009-218-40510090218401 TUBE in 1 CARTON (51009-218-40) > 113 g in 1 TUBE1 tube2018-11-130000-00-00NoNoCurrent