FDA.reportPublic FDA data

Dr.NOAH SOLIDTOOTHPASTE

Manufacturer
DR.Noah | SUNGWON PHARMACEUTICAL CO., LTD.
Effective date
2021-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:53

Label at a glance#

ProductDr.NOAH SOLIDTOOTHPASTE
Active ingredientSODIUM FLUORIDE, SILICON DIOXIDE, SODIUM PYROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

for oral use only

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate

PURPOSE

OTC - PURPOSE SECTION

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNING

WARNINGS SECTION

For oral use only
When using this product

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, seek medical help or contact the poison control center immediately

USES

DOSAGE & ADMINISTRATION SECTION

for oral use only

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist

do not swallow the tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82359-0003-12023-07-28C16284748780-10191ceaa-63e8-198a-e063-dbdaa90aec3ecf7c2791-c3b4-2163-e053-2995a90a4e8e
82359-0003-22023-07-28C16284748780-10191ceaa-63e8-198a-e063-dbdaa90aec3ecf7c2791-c3b4-2163-e053-2995a90a4e8e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82359-0003-1Dr.NOAH SOLIDTOOTHPASTE180 in 1 POUCHTABLET1801
82359-0003-2Dr.NOAH SOLIDTOOTHPASTE30 in 1 CASETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82359-0003DR.NOAH SOLIDTOOTHPASTE (SODIUM FLUORIDE) TABLET [DR.NOAH]1Legacy NDC, 2 package rows20211112_cf7c2791-c3b4-2163-e053-2995a90a4e8e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82359-000382359-0003-1, 82359-0003-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOIACT
SORBITOL506T60A25RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SODIUM PYROPHOSPHATEO352864B8ZACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB

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
cf7c2791-c3b5-2163-e053-2995a90a4e8ecf7c2791-c3b4-2163-e053-2995a90a4e8e2021-10-29WarningsExact identifier
spl id: cf7c2791-c3b5-2163-e053-2995a90a4e8e
spl set id: cf7c2791-c3b4-2163-e053-2995a90a4e8e

Reported adverse events (FAERS/openFDA)#

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