FDA.reportPublic FDA data

Dr.NOAH Toothpaste Tablets

Manufacturer
Project Noah Inc. | Sungwon Pharmaceutical Co., Ltd.
Effective date
2022-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:00

Label at a glance#

ProductDr.NOAH Toothpaste Tablets
Active ingredientSodium Fluoride
Label structure10 sections

Indications and uses

■ Helps protect against cavities, plaque, and gingivitis.

Dosage and administration

■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(1,000 ppm fluoride ion)

PURPOSE

OTC - PURPOSE SECTION

Anti-cavity

Uses

INDICATIONS & USAGE SECTION

■ Helps protect against cavities, plaque, and gingivitis.

Warnings

WARNINGS SECTION

Please keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children under 6 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Other Information

OTHER SAFETY INFORMATION

■ Store at 33.8-86℉(1-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D-Sorbitol, Silicon Dioxide, Sodium Cocoyl Glutamate, Xylitol, Tetrasodium Pyrophosphate, Microcrystalline Cellulose, Xanthan Gum, Sodium Bicarbonate, Magnesium Stearate, Enzymatically Modified Stevia, Hydroxypropylcellulose, Yuzu Extract, Sage Extract, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(Spearmint Flavor Powder), L-Menthol, Bamboo Salt, Pyridoxine Hydrochloride

Dr.NOAH Toothpaste Tablets (30 TABLETS)NDC: 82989-030-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello packImage of cello pack

Dr.NOAH Toothpaste Tablets (180 TABLETS)NDC: 82989-030-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello packImage of cello pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82989-030-012024-01-30C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc
82989-030-022024-01-30C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc
82989-030-012023-12-28C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc
82989-030-022023-12-28C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc
82989-030-012023-07-28C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc
82989-030-022023-07-28C16284748780-10191ceaa-6590-198a-e063-dbdaa90aec3e3fec6cda-62cc-4e13-a100-1411681c5bbc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82989-030-01Dr.NOAH Toothpaste Tablets30 in 1 CELLO PACKPASTE, DENTIFRICE301
82989-030-02Dr.NOAH Toothpaste Tablets180 in 1 CELLO PACKPASTE, DENTIFRICE1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82989-030DR.NOAH TOOTHPASTE TABLETS (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROJECT NOAH INC.]1Legacy NDC, 2 package rows20221014_3fec6cda-62cc-4e13-a100-1411681c5bbc.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
82989-03082989-030-01, 82989-030-02

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 Fluoride8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
Silicon DioxideETJ7Z6XBU4IACT
Sodium Cocoyl GlutamateBMT4RCZ3HGIACT

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
af0685db-7b12-42c3-9f8a-99c74dbef5903fec6cda-62cc-4e13-a100-1411681c5bbc2022-10-13WarningsExact identifier
spl id: af0685db-7b12-42c3-9f8a-99c74dbef590
spl set id: 3fec6cda-62cc-4e13-a100-1411681c5bbc

Reported adverse events (FAERS/openFDA)#

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