FDA.reportPublic FDA data

Hoo gargle (Rooibos Tea Flavor)(Mouthwash)

Manufacturer
MIKO CO LTD
Effective date
2023-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:29

Label at a glance#

ProductHoo gargle (Rooibos Tea Flavor)(Mouthwash)
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride

INACTIVE INGREDIENT SECTION

menthol

xylitol

Sodium acetate

Allanine
Acetic acid
Propolis
Chitosan
Green tea extract

Stevia
Cyclodextrin
Benzoic acid
Red ginsengs extract

Caramel
Grapefruit seed extract

Maple flavor
Rooibos tea flavor

Purified Water

OTC - PURPOSE SECTION

dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

1. Put one cup in mouth.

2. Gargle for 30 sec ~ 1 minute

3. Spit it out.

5. Rinse with water.

WARNINGS SECTION

Be careful not to swallow it, and rinse your mouth thoroughly after use.

DOSAGE & ADMINISTRATION SECTION

dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4
313029sodium fluoride 0.2 MG/ML MouthwashSCD4
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81840-2222-52024-07-30C16284748780-11030e365-186f-111a-e063-dadaa90a10e2Drug Facts
81840-2222-52024-01-30C16284748780-11030e365-186f-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81840-2222-0Hoo gargle (Rooibos Tea Flavor)(Mouthwash)10 mL in 1 POUCHLIQUID104
81840-2222-1Hoo gargle (Rooibos Tea Flavor)(Mouthwash)10 in 1 PACKAGELIQUID104
81840-2222-2Hoo gargle (Rooibos Tea Flavor)(Mouthwash)15 in 1 PACKAGELIQUID154
81840-2222-3Hoo gargle (Rooibos Tea Flavor)(Mouthwash)30 in 1 PACKAGELIQUID304
81840-2222-4Hoo gargle (Rooibos Tea Flavor)(Mouthwash)50 in 1 PACKAGELIQUID504
81840-2222-5Hoo gargle (Rooibos Tea Flavor)(Mouthwash)100 in 1 PACKAGELIQUID1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81840-2222HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH) (SODIUM FLOURIDE) LIQUID [MIKO CO LTD]4Legacy NDC, 6 package rows20231007_e9145a59-c7b4-48ac-e053-2a95a90a0bb3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81840-222281840-2222-0, 81840-2222-1, 81840-2222-2, 81840-2222-3, 81840-2222-4, 81840-2222-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
0707e17f-bfe8-5ce2-e063-6394a90a8cc2e9145a59-c7b4-48ac-e053-2a95a90a0bb32023-10-06WarningsExact identifier
spl id: 0707e17f-bfe8-5ce2-e063-6394a90a8cc2
spl set id: e9145a59-c7b4-48ac-e053-2a95a90a0bb3

Reported adverse events (FAERS/openFDA)#

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