FDA.reportPublic FDA data

Denti Whoo Bubble Concentrated Gargle

Manufacturer
SUN LIFE SCIENCE CO LTD
Effective date
2022-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:05

Label at a glance#

ProductDenti Whoo Bubble Concentrated Gargle
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride

INACTIVE INGREDIENT SECTION

Concentrated Glycerin
D-Sorbitol Solution
Propolis Extract
Chitosan
Grapefruit Seed Extract
Green Tea Extract
Eucalyptus Extract
Matricaria Extract
Steviol Glycoside
Xylitol
Peppermint Flavor
Gardenia Blue
Sodium Bicarbonate
Water

OTC - PURPOSE SECTION

Clean mouth, remove plaque, clean mouth, remove odors

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Three times a day, put 5 drops of the concentrated solution into a sealed cup, addwater to the marked line, brush your teeth (gargle) with dilute solution for about 30seconds, and spit it out

WARNINGS SECTION

1.Do not store it above 30°C2. Avoid exposure to heat, sparks and flames3. Be careful as it can irritate your eyes4.Wash with water when contacting eyes5. Store out of reach of infants and children

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2590919cetylpyridinium chloride 2.3 % Concentrated MouthwashPSN1
2590919cetylpyridinium chloride 23 MG/ML MouthwashSCD1
2590919cetylpyridinium chloride 2.296 % MouthwashSY1
2590919cetylpyridinium chloride 2.3 % MouthwashSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86157-0004-12023-07-28C16284748780-10191ceaa-6e0a-198a-e063-dbdaa90aec3edbf92ddf-ffc6-be65-e053-2995a90acfaa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86157-0004-1Denti Whoo Bubble Concentrated Gargle50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86157-0004DENTI WHOO BUBBLE CONCENTRATED GARGLE (CETYLPYRIDINIUM CHLORIDE) LIQUID [SUN LIFE SCIENCE CO LTD]1Legacy NDC, 1 package rows20220407_dbf92ddf-ffc6-be65-e053-2995a90acfaa.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
86157-000486157-0004-1

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
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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
dbf92ddf-ffc5-be65-e053-2995a90acfaadbf92ddf-ffc6-be65-e053-2995a90acfaa2022-04-06WarningsExact identifier
spl id: dbf92ddf-ffc5-be65-e053-2995a90acfaa
spl set id: dbf92ddf-ffc6-be65-e053-2995a90acfaa

Reported adverse events (FAERS/openFDA)#

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