Toms Teeth and Gum Health

Product NDC
51009-918
Requested package NDC
51009-918-40
11-digit product format
510090918
Labeler code
51009
Product ID
51009-918_176c0ea9-2d60-4d76-859a-695cf663d9a0
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
2021-11-30
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 mg/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 packagepackage51009-91851009-918-40DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-918TOMS TEETH AND GUM HEALTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]4Legacy NDC20241120_e4393409-5e7c-08b8-48fa-1c0408827917.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-918-40510090918401 TUBE in 1 CARTON (51009-918-40) > 113 g in 1 TUBE1 tube2021-11-300000-00-00NoNoCurrent