FDA.reportPublic FDA data

Beanguard Gargle Plus

Manufacturer
BIO3S Co.,Ltd.
Effective date
2022-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:27

Label at a glance#

ProductBeanguard Gargle Plus
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

Vigorously swish 10 mL of gargle between your teeth for 1 minute and then spit it out. Do not swallow.

Storage and handling

Store in an airtight container at room temperature (1~30℃).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities. Helps to refresh your breath.

Warnings

OTC - DO NOT USE SECTION

Do not use more or for longer than directed.

Warnings

OTC - WHEN USING SECTION

This product contains fluorine, so if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Warnings

OTC - STOP USE SECTION

Stop use and ask a dentist if oral irritiation or tooth sensitivity occurs.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, D-Sorbitol Solution, Concentrated Glycerin, Soybean Extract, Ethanol, Xylitol, Raspberry Extract, Sodium Alginate, Polyoxyethylene hydrogenated caster oil, Flavor, Sodium Benzoate, Menthol Pulegium Oil, L-Menthol, Sucralose, Sodium Fluoride, Citric acid, Sodium citrate, Green Tea Extract, Aloe Extract, Sage Extract

Other Information

STORAGE AND HANDLING SECTION

Store in an airtight container at room temperature (1~30℃).

Directions

DOSAGE & ADMINISTRATION SECTION

Vigorously swish 10 mL of gargle between your teeth for 1 minute and then spit it out.
Do not swallow.

Warnings

WARNINGS SECTION

Do not swallow.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Beanguard Gargle Plus LabelBeanguard Gargle Plus Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77935-303-012024-01-30C16284748780-11030e365-2f73-111a-e063-dadaa90a10e277935-303 Beanguard Gargle Plus
77935-303-022024-01-30C16284748780-11030e365-2f73-111a-e063-dadaa90a10e277935-303 Beanguard Gargle Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77935-303-01Beanguard Gargle Plus250 mL in 1 BOTTLE, PLASTICLIQUID2501
77935-303-02Beanguard Gargle Plus10 mL in 1 BOTTLE, PLASTICLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77935-303BEANGUARD GARGLE PLUS (SODIUM FLUORIDE) LIQUID [BIO3S CO.,LTD.]1Legacy NDC, 2 package rows20220504_dc1c793b-b636-f13a-e053-2995a90ace61.zip

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
77935-30377935-303-01, 77935-303-02

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
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SOYBEANL7HT8F1ZODIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
PENNYROYAL OILAK85U7Y3MVIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SUCRALOSE96K6UQ3ZD4IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
SODIUM ALGINATEC269C4G2ZQIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
ALOEV5VD430YW9IACT
CLARY SAGEU3HSK5JC0QIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
RASPBERRY4N14V5R27WIACT

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
dc1c793b-b637-f13a-e053-2995a90ace61dc1c793b-b636-f13a-e053-2995a90ace612022-04-07WarningsExact identifier
spl id: dc1c793b-b637-f13a-e053-2995a90ace61
spl set id: dc1c793b-b636-f13a-e053-2995a90ace61

Reported adverse events (FAERS/openFDA)#

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