FDA.reportPublic FDA data

TheraBreath™ Deep Clean Dentist Formulated Toothpaste, Fresh Mint

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-25 01:03:03

Label at a glance#

ProductTherabreath Deep Clean
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Indications and uses

• aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

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

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity/Antigingivitis

Uses

INDICATIONS & USAGE SECTION

• aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

WARNINGS SECTION

Warnings

Stop use and ask a dentist if

OTC - DO NOT USE SECTION

• gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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 ageinstruct 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, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, silica, sodium lauryl sulfate, flavor, sodium lauroyl sarcosinate, polyvinylpyrrolidone, titanium dioxide, xanthan gum, sucralose

Questions or Comments?

OTC - QUESTIONS SECTION

Therabreath™ is manufactured by

Church & Dwight Co., Inc., Ewing, NJ 02628 U.S.A.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LONG LASTING FOR EPIC FRESHNESS

TheraBreath™

DEEP CLEAN

DENTIST FORMULATED TOOTHPASTE

Anticavity/Antigingivitus

KILLS 99.9% OF GERMS

THAT CAUSE BAD BREATH, PLAQUE, AND GINGIVITIS*

TWIN PACK *in laboratory tests

Neutralizes the source of bad breath*

*in laboratory tests

Gently whitens

Dr. Harold Katz

Fresh Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)

TB Toothpaste Deep Clean 4 oz Twin CartonTB Toothpaste Deep Clean 4 oz Twin Carton

TB Deep Clean 4oz Toothpaste TubeTB Deep Clean 4oz Toothpaste Tube

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-27010237-270-24, 10237-270-04, 10237-270-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
PENTASODIUM TRIPHOSPHATE9SW4PFD2FZIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
PEG-8B697894SGQIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-01full-release2026-06-01 01:11:44

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 Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
ndc (package): 10237-270-07
ndc (package): 10237-270-24
ndc (package): 10237-270-04
ndc (product): 10237-270
ndc11 (package): 10237027024
ndc11 (package): 10237027007
ndc11 (package): 10237027004
spl id: 59905b26-6316-4aee-e063-6394a90a019f
spl set id: 3c372f26-e0c4-0659-e063-6294a90ae9f9

Reported adverse events (FAERS/openFDA)#

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