Home NDC 10237-265 TheraBreath Anticavity
Product NDC 10237-265
11-digit product format 102370265
Labeler code 10237
Product ID 10237-265_3e626c65-3a8b-ec3c-e063-6394a90ad8f4
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form RINSE
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-15
Substance SODIUM FLUORIDE
Active strength .002 mg/10mL
NDC exclude flag No
Listing certified through 2026-12-31
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 TheraBreath Anticavity
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .002 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 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 10237-265-01 TheraBreath Anticavity 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 3 10237-265-21 TheraBreath Anticavity 2 in 1 PACKAGE RINSE 2 3 10237-265-21 TheraBreath Anticavity 1000 mL in 1 BOTTLE RINSE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-265 THERABREATH ANTICAVITY (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.] 2 Current NDC, 3 package rows 20241129_3c5d58f1-ea8c-4708-bbc6-21e1cd1446da.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 40 of 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-265-01 10237026501 1000 mL in 1 BOTTLE, PLASTIC (10237-265-01) 1000 ml 2024-08-15 No No Current 10237-265-21 10237026521 2 BOTTLE in 1 PACKAGE (10237-265-21) / 1000 mL in 1 BOTTLE 2 bottle 2026-01-01 No No Current