FDA.reportPublic FDA data

TheraBreath Healthy Smile Oral Rinse

Manufacturer
Dr. Harold Katz, LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:48:01

Label at a glance#

ProductTheraBreath Healthy Smile Oral Rinse
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and Children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

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 and Children 6 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: consult a dentist or doctor.

Other Information

OTHER SAFETY INFORMATION

Do not use if safety seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate.

TheraBreath Healthy Smile Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy Smile Oral RinseHealthy Smile Oral Rinse

Healthy Smile Travel Size

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Travel SizeTravel Size

Healthy Smile Travel Pouch 0.25 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy Smile Travel Pouch 0.25 ozHealthy Smile Travel Pouch 0.25 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN8
240698sodium fluoride 0.5 MG/ML MouthwashSCD8
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY8

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72551-246-012024-01-30C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-022024-01-30C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-032024-01-30C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-042024-01-30C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-012021-02-10C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-022021-02-10C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-032021-02-10C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-012021-01-29C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-022021-01-29C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse
72551-246-032021-01-29C16284748780-1ba0f9c33-3a2f-a910-e053-dadaa90a0b85TheraBreath Healthy Smile Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72551-246-01TheraBreath Healthy Smile Oral Rinse473 g in 1 BOTTLE, PLASTICRINSE4738
72551-246-02TheraBreath Healthy Smile Oral Rinse85 g in 1 BOTTLE, PLASTICRINSE858
72551-246-03TheraBreath Healthy Smile Oral Rinse7 g in 1 POUCHRINSE78
72551-246-04TheraBreath Healthy Smile Oral Rinse958.21 g in 1 BOTTLERINSE958.218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72551-246THERABREATH HEALTHY SMILE ORAL RINSE (SODIUM FLUORIDE) RINSE [DR. HAROLD KATZ, LLC]8Legacy NDC, 4 package rows20220205_7f0e6864-5577-e368-e053-2a91aa0a57ca.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72551-24672551-246-01, 72551-246-02, 72551-246-03, 72551-246-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEMON OILI9GRO824LLIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AIACT
SODIUM CHLORITEG538EBV4VFIACT
MENTHA PIPERITA79M2M2UDA9IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML · Source PDF

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
d7352a14-9f43-8d5b-e053-2995a90ab63b7f0e6864-5577-e368-e053-2a91aa0a57ca2022-02-04WarningsExact identifier
spl id: d7352a14-9f43-8d5b-e053-2995a90ab63b
spl set id: 7f0e6864-5577-e368-e053-2a91aa0a57ca

Reported adverse events (FAERS/openFDA)#

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