Home NDC 51009-857 TOMS OF MAINE WHOLE CARE SPEARMINT
Product NDC 51009-857
11-digit product format 510090857
Labeler code 51009
Product ID 51009-857_c3c4f6f5-4dc8-41d4-aaa5-15f1f1eabd4a
Type HUMAN OTC DRUG
Nonproprietary name Sodium monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Tom's of Maine, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TOMS OF MAINE WHOLE CARE SPEARMINT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51009-857-69 Tom Whole Care Peppermint SLS Freefights cavities whitening fresh breath helps fight tartar 113 g in 1 TUBE PASTE, DENTIFRICE 113 1 51009-857-69 Tom Whole Care Peppermint SLS Freefights cavities whitening fresh breath helps fight tartar 1 in 1 CARTON PASTE, DENTIFRICE 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 38 of 49 · 974 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51009-857-69 51009085769 1 TUBE in 1 CARTON (51009-857-69) / 113 g in 1 TUBE 1 tube 2025-12-01 No No Current