FDA.reportPublic FDA data

Beanguard Gargle

Manufacturer
BIO3S Co.,Ltd.
Effective date
2021-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:47

Label at a glance#

ProductBeanguard Gargle
Active ingredientSODIUM CHLORIDE
Label structure12 sections

Indications and uses

Helps maintain the hygiene of the oral cavity.Gives ongoing freshness and helps prevent cavities with removing bad breath.

Dosage and administration

Take one pouch and gargle for 30 seconds. Do not swallow and spit it out

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.5%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

DOSAGE & ADMINISTRATION SECTION

Helps maintain the hygiene of the oral
cavity.Gives ongoing freshness and helps
prevent cavities with removing bad breath.

Warnings

OTC - DO NOT USE SECTION

Do not swallow.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years old.

If accidently swallowed, get medical help or consult with doctor

Warnings

OTC - STOP USE SECTION

Stop Use and Ask a Doctor if : red spots, swelling, itching symptoms occur.

Warnings

OTC - WHEN USING SECTION

When Using this product : Be careful not to swallow or get into eyes or ears.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sodium benzoate, bean extract

Directions

INDICATIONS & USAGE SECTION

Take one pouch and gargle for 30 seconds.
Do not swallow and spit it out

Other Information

OTHER SAFETY INFORMATION

Other information
Avoid exposing the product in direct sunlight
and excessive heat. Store at room temperature
20°-25°C (68°-77°F

Warnings

WARNINGS SECTION

If accidently swallowed, get medical help or consult with doctor.

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Beanguard GargleBeanguard Gargle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2584855sodium chloride 0.5 % Oral RinsePSN1
2584855sodium chloride 5 MG/ML MouthwashSCD1
2584855NaCl 5 MG/ML MouthwashSY1
2584855sodium chloride 0.5 % Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77935-302-012023-01-30C16284748780-1f386c649-a895-0266-e053-dadaa90a7c1a77935-302 Beanguard Gargle

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77935-302-01Beanguard Gargle5 mL in 1 BOTTLE, PLASTICLIQUID51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77935-302BEANGUARD GARGLE (SODIUM CHLORIDE) LIQUID [BIO3S CO.,LTD.]1Legacy NDC, 1 package rows20211106_cdd52344-bfbe-19ce-e053-2a95a90ab2db.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
77935-30277935-302-01

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
SODIUM CHLORIDE451W47IQ8XACTIB
BEAN8WB9PV3YW5IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
d002e84b-94c0-4201-e053-2995a90aa8bbcdd52344-bfbe-19ce-e053-2a95a90ab2db2021-10-08WarningsExact identifier
spl id: d002e84b-94c0-4201-e053-2995a90aa8bb
spl set id: cdd52344-bfbe-19ce-e053-2a95a90ab2db

Reported adverse events (FAERS/openFDA)#

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