FDA.reportPublic FDA data

TheraBreath Plus Fresh Breath

Manufacturer
Dr. Harold Katz, LLC
Effective date
2022-02-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:47:56

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%

(0.14% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Fluoride Dentrifice

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

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

OTHER SAFETY INFORMATION

  • 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)

TheraBreath Fresh Breath Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fresh Breath ToothpasteFresh Breath Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN5
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD5
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72551-251-012024-01-30C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath
72551-251-022024-01-30C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath
72551-251-012021-02-10C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath
72551-251-022021-02-10C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath
72551-251-012021-01-29C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath
72551-251-022021-01-29C16284748780-1ba0f9c33-42d2-a910-e053-dadaa90a0b85TheraBreath Plus Fresh Breath

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72551-251-01TheraBreath Plus Fresh Breath1 in 1 PACKAGEPASTE, DENTIFRICE15
72551-251-01TheraBreath Plus Fresh Breath113.5 g in 1 TUBEPASTE, DENTIFRICE113.55
72551-251-02TheraBreath Plus Fresh Breath21.3 g in 1 TUBEPASTE, DENTIFRICE21.35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72551-251THERABREATH PLUS FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [DR. HAROLD KATZ, LLC]5Legacy NDC, 3 package rows20220204_7c499cf1-bcac-2782-e053-2a91aa0a01bf.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72551-25172551-251-01, 72551-251-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
UBIDECARENONEEJ27X76M46IACT
SPEARMINTJ7I2T6IV1NIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SODIUM CHLORITEG538EBV4VFIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
d723d2aa-6d99-6bd2-e053-2a95a90a9c757c499cf1-bcac-2782-e053-2a91aa0a01bf2022-02-03WarningsExact identifier
spl id: d723d2aa-6d99-6bd2-e053-2a95a90a9c75
spl set id: 7c499cf1-bcac-2782-e053-2a91aa0a01bf

Reported adverse events (FAERS/openFDA)#

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