Tooth

Manufacturer
Henan Dailygreen Biotechnology Co. LTD
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:51

Label at a glance#

ProductTooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Dosage and administration

Adults : Wet your toothbrush and crush the tab between your teeth Brush like normal. Rinse after using . Brushteeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Storage and handling

Store at room temperature and dry place.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium monofluorophosphate 0.877% (1100ppm w/v fluoride ion )

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children Not to be used by children under 12 years of age. If more than used for brushing isaccidentally swallowed get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Not to be used by children under 12 years of age .

OTC - WHEN USING SECTION

n/a

OTC - STOP USE SECTION

n/a

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Adults : Wet your toothbrush and crush the tab between your teeth Brush like normal. Rinse after using . Brushteeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature and dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol , Calcium Carbonate , Probiotics , Xylitol , Magnesium Stearate , Stevia Rebaudiana Extract ,Tea ( Camellia Sinensis ) Polyphenols , Peppermint ( Mentha Piperita ) oil , Bitter Orange ( Citrus Aurantium ) Flower Oil , Peppermint ( Mentha Piperita ) Leaf oil , Cocamidopropyl Betaine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83861-001-0183861-001-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83861-001-012025-01-30C16284748780-12cef2736-83a2-d83d-e063-dadaa90ab31f83861-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83861-001-01Tooth6 in 1 BOXTABLET62
83861-001-02Tooth60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83861-001TOOTH (TOOTHPASTE TABLETS) TABLET [HENAN DAILYGREEN BIOTECHNOLOGY CO. LTD]22 package rows20231212_0c32911a-4029-01d8-e063-6294a90a9a90.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83861-00183861-001-02, 83861-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
0c389ae5-8708-7ded-e063-6394a90a39450c32911a-4029-01d8-e063-6294a90a9a902023-12-11WarningsExact identifier
spl id: 0c389ae5-8708-7ded-e063-6394a90a3945
spl set id: 0c32911a-4029-01d8-e063-6294a90a9a90

Reported adverse events (FAERS/openFDA)#

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