Home NDC 10237-273 TheraBreath
Product NDC 10237-273
11-digit product format 102370273
Labeler code 10237
Product ID 10237-273_59906b37-9bbf-710d-e063-6294a90abee4
Type HUMAN OTC DRUG
Nonproprietary name Potassium nitrate, Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-15
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .24; 5 g/100g; g/100g
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 TheraBreath
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .24 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 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 10237-273-04 TheraBreath 1 in 1 CARTON PASTE, DENTIFRICE 1 1 10237-273-04 TheraBreath 113 g in 1 TUBE PASTE, DENTIFRICE 113 1 10237-273-24 TheraBreath 113 g in 1 TUBE PASTE, DENTIFRICE 113 1 10237-273-24 TheraBreath 2 in 1 CARTON PASTE, DENTIFRICE 2 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 39 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 10237-273-04 10237027304 1 TUBE in 1 CARTON (10237-273-04) / 113 g in 1 TUBE 1 tube 2026-01-15 No No Current 10237-273-07 10237027307 1 TUBE in 1 CARTON (10237-273-07) / 19 g in 1 TUBE 1 tube 2026-08-21 No No Current 10237-273-24 10237027324 2 TUBE in 1 CARTON (10237-273-24) / 113 g in 1 TUBE 2 tube 2026-01-15 No No Current