FDA.reportPublic FDA data

TheraBreath Plus Fresh Breath

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:45:20

Label at a glance#

ProductTheraBreath Plus Fresh Breath
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults & 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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

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 Fluoride Dentifrice

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

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

Adults & 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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult 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 (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL - 113.5 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY TOOTHPASTE

CLINICAL FORMULA
TheraBreath ®
PLUS

MAXIMUM STRENGTH

FRESH BREATH

TOOTHPASTE

FRESHENS BREATH FOR 24 HOURS*

Fortified with Zinc, Xylitol and Aloe
Nothing Works Faster and Lasts Longer
to Prevent Bad Breath

Dr. Harold Katz

net wt. 4 oz. • 113.5 g

PEPPERMINT

Principal Display Panel - 113.5 g Tube Label
Principal Display Panel - 113.5 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-26410237-264-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORITEG538EBV4VFIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
UBIDECARENONEEJ27X76M46IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
SPEARMINT OILC3M81465G5IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT

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
4519cc2a-5c1b-5d6d-e063-6394a90a13b9a4dba786-df60-4b4f-85d9-636e275664af2025-12-03WarningsExact identifier
spl id: 4519cc2a-5c1b-5d6d-e063-6394a90a13b9
spl set id: a4dba786-df60-4b4f-85d9-636e275664af

Reported adverse events (FAERS/openFDA)#

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