FDA.reportPublic FDA data

OraBalance dentalcare

Manufacturer
isamogu Inc.
Effective date
2022-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:19

Label at a glance#

ProductOraBalance dentalcare
Active ingredientLACTOBACILLUS GASSERI, LIMOSILACTOBACILLUS FERMENTUM
Label structure11 sections

Dosage and administration

Melt one tablet slowly in your mouth and eat 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 and eat once

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Oligosaccharide 3(Palatinos, Maltitol Syrup, Galacto-oligosaccharide)
xylitol
isomalt
maltodextrin
grape flavor powder
vitamin C
Magnesium Stearate
Calcium Pantothenate
silicon dioxide
vitamin E
vitamin K2
collagen

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82690-401
OraBalance Dentalcare

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82690-401-012024-01-30C16284748780-11030e365-4bec-111a-e063-dadaa90a10e282690-401 OraBalance Dentalcare

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82690-401-01OraBalance dentalcare24 g in 1 BOXTABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82690-401ORABALANCE DENTALCARE (LACTOBACILLUS GASSERI HHUMIN, LACTOBACILLUS FERMENTUM OK) TABLET [ISAMOGU INC.]1Legacy NDC, 1 package rows20220803_e3ab5461-bda5-e7f8-e053-2995a90a8211.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82690-40182690-401-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENAQUINONE 671ANL51TLAIACT
COLLAGEN, SOLUBLE, FISH SKIN8JC99XGU4WIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CITRUS PARADISI WHOLE3FNT9K2294IACT
LACTOBACILLUS GASSERIQ66E0D2443ACTIB
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
ISOMALTULOSE ANHYDROUSV59P50X4UYIACT
4'-GALACTOSYLLACTOSEB8CW1B3F6RIACT
MALTITOLD65DG142WKIACT
XYLITOLVCQ006KQ1EIACT
ISOMALTS870P55O2WIACT
MALTODEXTRIN7CVR7L4A2DIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
MAGNESIUM STEARATE70097M6I30IACT

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
e3ab5461-bda6-e7f8-e053-2995a90a8211e3ab5461-bda5-e7f8-e053-2995a90a82112022-07-13WarningsExact identifier
spl id: e3ab5461-bda6-e7f8-e053-2995a90a8211
spl set id: e3ab5461-bda5-e7f8-e053-2995a90a8211

Reported adverse events (FAERS/openFDA)#

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