Home DailyMed 4618e390-9039-a1d0-e063-6294a90ab294 TheraBreath Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Church & Dwight Co., Inc.
Effective date 2025-12-16
Label type HUMAN OTC DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-06-01 01:25:54 Label at a glance# Product TheraBreath AM-PM Twin Pack
Active ingredient SODIUM FLUORIDE
Label structure 8 sections
Dosage and administration Adults 18 years of age or older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink 30 minutes after rinsing
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 240698 sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse PSN 1 240698 sodium fluoride 0.5 MG/ML Mouthwash SCD 1 240698 sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse SY 1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-268-01 TheraBreathAM-PM Twin Pack 1 in 1 CARTON KIT 1 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 14 matching rows.
TheraBreath AM-PM Twin Pack Sodium Fluoride Therabreath Overnight Chamomile Mint WATER GLYCERIN SODIUM BENZOATE SODIUM HYDROXIDE SODIUM CHLORITE CITRIC ACID MONOHYDRATE SUCRALOSE FLUORIDE ION POLYOXYL 40 HYDROGENATED CASTOR OIL TheraBreath Fresh Breath Oral Rinse Invigorating Icy Mint Not Applicable Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 9 matching rows.
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 1 of 1 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.