FDA.reportPublic FDA data

OraBalance Breathcare

Manufacturer
isamogu Inc.
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:55:46

Label at a glance#

ProductOraBalance Breathcare
Active ingredientLACTOBACILLUS GASSERI, LIMOSILACTOBACILLUS FERMENTUM
Label structure11 sections

Dosage and administration

Melt one tablet slowly in your mouth at once

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lactobacillus gasseri HHuMin
Lactobacillus fermentum OK

Purpose

OTC - PURPOSE SECTION

Eliminate Bad Breath

use

INDICATIONS & USAGE SECTION

Improve oral health care

Warnings

OTC - DO NOT USE SECTION

do not eat silica gel

Warnings

OTC - WHEN USING SECTION

be careful, as you may get hurt when opening it.

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

WARNINGS SECTION

avoid direct sunlight and store it in a dry, ventilated, cool place.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Melt one tablet slowly in your mouth at once

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isomalt, Oligosaccharide 3(Palatinos, Maltitol Syrup, Galacto-oligosaccharide), Xylitol, Maltodextrin, Spearmint extract, Magnesium Stearate, Bifidobacterium bifidum BGN4, Bifidobacterium animalis ssp. lactis AD011, Bifidobacterium longum BORI, vitamin C, Nicotinamide, Calcium Pantothenate, vitamin B2, Vitamin B1 Hydrochloride, Vitamin B6 Hydrochloride, Gum arabic, Saccharose, Corn Starch, Processed Fat, Silicon Dioxide, Vitamin D3, Vitamin E, Dextrin, Sodium Citrate, Citric Acid, VitaminB12

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82690-402

OraBalance Breathcare labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82690-402-012024-07-29C16284748780-11030e365-6a13-111a-e063-dadaa90a10e282690-402 OraBalance Breathcare
82690-402-012024-01-30C16284748780-11030e365-6a13-111a-e063-dadaa90a10e282690-402 OraBalance Breathcare

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82690-40282690-402-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CHOLECALCIFEROL1C6V77QF41IACT
RIBOFLAVINTLM2976OFRIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
THIAMINE HYDROCHLORIDEM572600E5PIACT
ACACIA5C5403N26OIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTOBACILLUS GASSERIQ66E0D2443ACTIB
ISOMALTULOSE ANHYDROUSV59P50X4UYIACT
MALTITOLD65DG142WKIACT
SUCROSEC151H8M554IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
BIFIDOBACTERIUM BIFIDUM BGN4YHK9HJP3KKIACT
4'-GALACTOSYLLACTOSEB8CW1B3F6RIACT
MALTODEXTRIN7CVR7L4A2DIACT
SPEARMINTJ7I2T6IV1NIACT
BIFIDOBACTERIUM LONGUM831AQW699WIACT
NIACINAMIDE25X51I8RD4IACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CYANOCOBALAMINP6YC3EG204IACT
BIFIDOBACTERIUM ANIMALIS LACTIS5307V7XW8IIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APACTIB
ISOMALTS870P55O2WIACT
XYLITOLVCQ006KQ1EIACT

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
1e6498ea-b45a-8260-e063-6294a90a4fbbe53ee262-5fe8-ed0c-e053-2995a90a8ece2024-07-29WarningsExact identifier
spl set id: e53ee262-5fe8-ed0c-e053-2995a90a8ece

Reported adverse events (FAERS/openFDA)#

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