TheraBreath Complete Oral Rinse

Manufacturer
Church & Dwight Co., Inc. | Applied Laboratories, Inc.
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:23

Label at a glance#

ProductTheraBreath Complete Oral Rinse
Active ingredientSODIUM FLUORIDE
Label structure8 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

Label contents#

Full prescribing information#

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

OTHER SAFETY INFORMATION

• 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, flavor, sodium benzoate, sucralose, sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TB CompleteTB Complete

NO ALCOHOL,

NON BURNING

ANTICAVITY FLUORIDE RINSE

THERABREATH TM

DENTIST FORMULATED

COMPLETE

ORAL RINSE

6 BENEFITS IN 1

Fights Cavities • Freshens Breath

Kills Bad Breath Bacteria • Cleans Whole Mouth

Strengthens Teeth • Helps Rebuild Enamel

Dr. Harold Katz

REVITALIZING MINT

IMPORTANT: Read directions for proper use.

16 fl. oz. (1 pt.) 473 mL

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
10237-267-16TheraBreath Complete Oral Rinse473 mL in 1 BOTTLERINSE4732
10237-267-26TheraBreath Complete Oral Rinse2 in 1 PACKAGERINSE22
10237-267-26TheraBreath Complete Oral Rinse473 mL in 1 BOTTLERINSE4732

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
10237-26710237-267-16, 10237-267-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 Complete Oral RinseANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.27c33ae1-52c7-baad-e063-6394a90a06112026-02-23WarningsExact identifier
ndc (package): 10237-267-16
ndc (package): 10237-267-26
ndc (product): 10237-267
ndc11 (package): 10237026716
ndc11 (package): 10237026726
spl id: 4b7fc579-156a-6f86-e063-6394a90ab66a
spl set id: 27c33ae1-52c7-baad-e063-6394a90a0611

Reported adverse events (FAERS/openFDA)#

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