FDA.reportPublic FDA data

Therabreath™ Whitening Dentist Formulated Toothpaste

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-25 01:03:03

Label at a glance#

ProductTherabreath Whitening
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

• do not swallow • supervise children as necessary until capable of using without supervision adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years of age consult a dentist or doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.17% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

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

Directions

DOSAGE & ADMINISTRATION SECTION

• do not swallow • supervise children as necessary until capable of using without supervision

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
children under 6 years of age

instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years of ageconsult a dentist or doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, sodium tripolyphosphate, flavor, sodium lauryI sulfate, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide, sodium saccharin, sucralose

Questions or Comments?

OTC - QUESTIONS SECTION

TheraBreath is manufactured by

Church & Dwight Co., Inc. Ewing, NJ 08628 U.S.A.

Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM

Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LONG LASTING FOR EPIC FRESHNESS

TheraBreath ™

WHITENING

DENTIST FORMULATED TOOTHPASTE

Anticavity

SIGNIFICANTLY WHITENS AFTER 1 WEEK*

TWIN PACK *with twice daily brushing

Neutralizes the source of bad breath t

tin laboratory tests

Gently whitens

Dr. Harold Katz

Dazzling Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)

TB Whitening Toothpaste 4 oz Twin CartonTB Whitening Toothpaste 4 oz Twin Carton

TB Whitening Toothpaste 4 oz TubeTB Whitening Toothpaste 4 oz Tube

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

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-27210237-272-24, 10237-272-04, 10237-272-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
GLYCERINPDC6A3C0OXIACT
SODIUM SACCHARINSB8ZUX40TYIACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-08-14full-release2026-06-01 01:10:33

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 WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
ndc (package): 10237-272-04
ndc (package): 10237-272-07
ndc (package): 10237-272-24
ndc (product): 10237-272
ndc11 (package): 10237027224
ndc11 (package): 10237027204
ndc11 (package): 10237027207
spl id: 59903e71-6c38-3ffb-e063-6294a90afad7
spl set id: 3ba04b55-38f9-76f3-e063-6394a90a3c03

Reported adverse events (FAERS/openFDA)#

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