TheraBreath

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#

ProductTheraBreath AM-PM Twin Pack
Active ingredientSODIUM FLUORIDE
Label structure8 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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Overnight Oral Rinse

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TheraBreath AM + PM TWIN PACK

AM

POWERED BY OXYGEN TM

INVIGORATING ICY MINT

PM

ANTICAVITY FLUORIDE RINSE

CHAMOMILE MINT

Helps prvent cavities and rebuild enamel

Add TheraBreath to your swishy time routine both day + night!

Fights bad breath for 12 hours

72030753 TB AM-PM Combo Carton72030753 TB AM-PM Combo Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-268-01TheraBreathAM-PM Twin Pack1 in 1 CARTONKIT11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-26810237-268-01
10237-262

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraBreath AM-PM Twin PackSODIUM FLUORIDEChurch & Dwight Co., Inc.4618e390-9039-a1d0-e063-6294a90ab2942025-12-16WarningsExact identifier
ndc (package): 10237-268-01
ndc (product): 10237-268
ndc11 (package): 10237026801
spl id: 4618e390-903a-a1d0-e063-6294a90ab294
spl set id: 4618e390-9039-a1d0-e063-6294a90ab294
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
ndc (product): 10237-262

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.