TheraBreath Anticavity

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-09-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:14:15

Label at a glance#

ProductTheraBreath Anticavity
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults 18 years of age and older: use twice 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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 18 years of age and older:

  • use twice 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, citrus lemon peel oil, Mentha piperita oil, sodium benzoate, sucralose, xylitol, sodium bicarbonate

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY FLUORIDE RINSE

USE 2X
DAILY

TheraBreath ™
DENTIST FORMULATED
ANTICAVITY
ORAL RINSE

HELPS FIGHT CAVITIES FOR 24 HOURS*
STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH
Helps rebuild weakened tooth enamel and prevent tooth decay
No Alcohol • With Fluoride • Non-Burning

Sodium Fluoride 0.02%
IMPORTANT:
Read directions for proper use.

33.8 FL OZ
(1.05 QT) 1 L

SPARKLE MINT

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-265-01TheraBreath Anticavity1000 mL in 1 BOTTLE, PLASTICRINSE10003
10237-265-21TheraBreath Anticavity2 in 1 PACKAGERINSE23
10237-265-21TheraBreath Anticavity1000 mL in 1 BOTTLERINSE10003

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-26510237-265-01, 10237-265-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
ndc (package): 10237-265-21
ndc (package): 10237-265-01
ndc (product): 10237-265
ndc11 (package): 10237026501
ndc11 (package): 10237026521
spl id: 3e626c65-3a8b-ec3c-e063-6394a90ad8f4
spl set id: 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da

Reported adverse events (FAERS/openFDA)#

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