TheraBreath Whitening - Anticavity Variety Pack

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-11 03:02:46

Label at a glance#

ProductTheraBreath
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and Children 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 for 30 minutes after rinsing.

Storage and handling

Do not use if safety seal is broken or missing Rinses are not intended to be used together. Always read and follow the product labels.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Anticavity 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

WARNINGS SECTION

Whitening Oral Rinse

Keep out of reach of children under 12 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

If spilled on fabrics, wash out immediately. This product was sealed with protective packaging. If seal is broken or missing, do not use.

Anticavity Oral Rinse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 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 for 30 minutes after rinsing.

Other information

STORAGE AND HANDLING SECTION

Do not use if safety seal is broken or missing

Rinses are not intended to be used together. Always read and follow the product labels.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

TheraBreath Whitening Fresh Breath Oral Rinse Dazzling Mint

SPL UNCLASSIFIED SECTION

Directions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TheraBreath TM WHITENING + ANTICAVITY

VARIETY PACK

TheraBreath TM DENTIST FORMULATED

WHITENING DAZZLING MINT TM + ANTICAVITY SPARKLE MINT

ORAL RINSE VARIETY PACK

Helps remove stains and prevent future staining

Helps fight cavities for 12 hours*

*For cavity protection, use as directed.

2 BOTTLES 16 FL OZ (1 PT) 473 mL EACH;

32 FL OZ (1QT) 946mL TOTAL

IMPORTANT:

Read directions for proper use.

TB Whitening-Anticavity Combo 72036907TB Whitening-Anticavity Combo 72036907

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-27410237-274-01
10237-26010237-260-16

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-01daily-update2026-06-11 05:11:25

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
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
ndc (package): 10237-260-16
ndc (package): 10237-274-01
ndc (product): 10237-274
ndc11 (package): 10237027401
ndc11 (package): 10237026016
spl id: 5b11930d-111a-400e-e063-6294a90a9e6b
spl set id: 53c1086d-264b-9d00-e063-6394a90ad19d
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
ndc (package): 10237-260-16
ndc (product): 10237-260
ndc11 (package): 10237026016

Reported adverse events (FAERS/openFDA)#

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