Home NDC 10237-263 TheraBreath Fresh Breath Anticavity Mild Mint
Product NDC 10237-263
11-digit product format 102370263
Labeler code 10237
Product ID 10237-263_679b3591-0e35-4795-b75c-131588fefc34
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-08
Substance SODIUM FLUORIDE
Active strength .24 g/100g
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 Fresh Breath Anticavity Mild Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .24 g/100g
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 416783 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 10237-263-04 TheraBreath Fresh Breath Anticavity Mild Mint 113.5 g in 1 TUBE PASTE, DENTIFRICE 113.5 1 10237-263-04 TheraBreath Fresh Breath Anticavity Mild Mint 1 in 1 CARTON PASTE, DENTIFRICE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-263 THERABREATH FRESH BREATH ANTICAVITY MILD MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 Current NDC, 2 package rows 20240208_19ce5324-7d8d-4d70-ad9b-238f7e612eac.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 35 of 51 · 1,013 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 10237-263-04 10237026304 1 TUBE in 1 CARTON (10237-263-04) / 113.5 g in 1 TUBE 1 tube 2024-02-08 No No Current