FDA.reportPublic FDA data

TheraBreath Fresh Breath Anticavity Mild Mint

Manufacturer
Church & Dwight Co., Inc. | Strukmyer Medical
Effective date
2024-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:24

Label at a glance#

ProductTheraBreath Fresh Breath Anticavity Mild Mint
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental decay.

Dosage and administration

Do not swallow. Supervise children as necessary until capable of using without supervision. Adults and children 6 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. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.14% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

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 6 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. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at the laboratory.
  • If seal is missing, do not use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST FORMULATED
FIGHTS CAVITIES
FIGHTS BAD BREATH FOR 12H*

ANTICAVITY FLUORIDE TOOTHPASTE

TheraBreath™
DENTIST FORMULATED
FRESH BREATH
TOOTHPASTE

FIGHTS CAVITIES
FIGHTS BAD BREATH FOR 12 HOURS*

AntiCavity
With Aloe Vera

Net Wt. 4 oz. • 113.5 g

MILD MINT

Read back panel for current directions

FIGHTS BAD BREATH FOR 12 HOURS*

PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-263-04TheraBreath Fresh Breath Anticavity Mild Mint113.5 g in 1 TUBEPASTE, DENTIFRICE113.51
10237-263-04TheraBreath Fresh Breath Anticavity Mild Mint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-263THERABREATH FRESH BREATH ANTICAVITY MILD MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1Current NDC, 2 package rows20240208_19ce5324-7d8d-4d70-ad9b-238f7e612eac.zip

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
10237-26310237-263-04

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
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORITEG538EBV4VFIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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 Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
ndc (package): 10237-263-04
ndc (product): 10237-263
ndc11 (package): 10237026304
spl id: 679b3591-0e35-4795-b75c-131588fefc34
spl set id: 19ce5324-7d8d-4d70-ad9b-238f7e612eac

Reported adverse events (FAERS/openFDA)#

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