FDA.reportPublic FDA data

DENTI WHOO BLUE TABLETGARGLE

Manufacturer
SUN LIFE SCIENCE CO LTD
Effective date
2022-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:36

Label at a glance#

ProductDENTI WHOO BLUE TABLETGARGLE
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride

INACTIVE INGREDIENT SECTION

Sodium Bicarbonate
Tartaric Acid
Hydroxypropylcellulose
Hydroxypropyl methylcellulose
Silica
Zea Mays (Corn) Starch
Sodium Cocoyl Glutamate
Maltitol
Mannitol
Erythritol
Potassium Acesulfame
Magnessium Stearate
Brilliant Blue
Menthol
Yucca Vera Leaf/Root Extract

fragrance

OTC - PURPOSE SECTION

Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

WARNINGS SECTION

1) Observe the specified usage capacity.
2) Store in a cool place with no sunlight and less moisture.
3) Avoid swallowing.
4) This product contains 583 ppm of fluorine.
5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist
immediately.
6) When used by children under the age of 6, use under the supervision of their guardians to
avoid swallowing.
7) Keep out of reach of children under the age of 6

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86157-0014-12023-07-28C16284748780-10191ceaa-6c7e-198a-e063-dbdaa90aec3edf330e62-e8cd-7b1f-e053-2a95a90ac0ba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86157-0014-1DENTI WHOO BLUE TABLETGARGLE8 in 1 PACKAGETABLET81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86157-0014DENTI WHOO BLUE TABLETGARGLE (SODIUM FLUORIDE) TABLET [SUN LIFE SCIENCE CO LTD]1Legacy NDC, 1 package rows20220518_df330e62-e8cd-7b1f-e053-2a95a90ac0ba.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86157-001486157-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HIACT
MALTITOLD65DG142WKIACT
SODIUM BICARBONATE8MDF5V39QOIACT
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
df330e62-e8ce-7b1f-e053-2a95a90ac0badf330e62-e8cd-7b1f-e053-2a95a90ac0ba2022-05-17WarningsExact identifier
spl id: df330e62-e8ce-7b1f-e053-2a95a90ac0ba
spl set id: df330e62-e8cd-7b1f-e053-2a95a90ac0ba

Reported adverse events (FAERS/openFDA)#

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