Home NDC 51009-837 Toms Whole Care Mouthwash Fresh Mint
Product NDC 51009-837
11-digit product format 510090837
Labeler code 51009
Product ID 51009-837_8501741f-1ce5-422a-ab07-d28fd65ef827
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form RINSE
Route DENTAL
Labeler Tom's of Maine, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-12-08
Substance SODIUM FLUORIDE
Active strength 1 mg/10mL
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 Whole Care Mouthwash Fresh Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313029 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51009-837-52 Toms Whole Care Mouthwash Fresh Mint 473 mL in 1 BOTTLE RINSE 473 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51009-837 TOMS WHOLE CARE MOUTHWASH FRESH MINT (SODIUM FLUORIDE) RINSE [TOM'S OF MAINE, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240119_6875f5c1-853c-43da-8226-c09a5518f9bb.zip
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 33 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51009-837-52 51009083752 473 mL in 1 BOTTLE (51009-837-52) 473 ml 2017-12-08 0000-00-00 No No Current