Home NDC 51009-149-06 Simply White
Product NDC 51009-149
Requested package NDC 51009-149-06
11-digit product format 510090149
Labeler code 51009
Product ID 51009-149_6994f570-94a3-4bc0-97fd-ee6f7f99bb08
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 2010-03-12
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 51009-149 51009-149-06 I Inactivated by FDA excluded / ndc_excluded.zip 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 SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 fluoride ion ACTIVE MOIETY Q80VPU408O SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Carrageenan INACTIVE INGREDIENT 5C69YCD2YJ SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Menthol INACTIVE INGREDIENT L7T10EIP3A SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Peppermint oil INACTIVE INGREDIENT AV092KU4JH SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Xanthan gum INACTIVE INGREDIENT TTV12P4NEE SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1 Xylitol INACTIVE INGREDIENT VCQ006KQ1E SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51009-149 SIMPLY WHITE SWEET MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.] 6 Legacy NDC 20241120_55df245e-8e79-4d52-a591-6c45d3b92945.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51009-149-06 51009014906 1 TUBE in 1 CARTON (51009-149-06) > 133.2 g in 1 TUBE 1 tube 2010-03-12 0000-00-00 No No Current