Tooth

Manufacturer
Henan Dailygreen Cosmetics Supplies Co.,Ltd.
Effective date
2025-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:09

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. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place....

Storage and handling

Store at room temperature and dry place.

Label contents#

Full prescribing information#

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 is accidentally swallowed get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not swallow. Do not use if seal is broken or missing. Not suitable for children under 12.

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. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12.

STORAGE AND HANDLING SECTION

Store at room temperature and dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients: 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

85346-001-0185346-001-01

85346-001-0285346-001-02

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85346-001-01Tooth6 in 1 BOXTABLET61
85346-001-01Tooth60 in 1 BOTTLETABLET601
85346-001-02Tooth3 in 1 BOXTABLET31
85346-001-02Tooth60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85346-001TOOTH (TOOTHPASTE TABLETS) TABLET [HENAN DAILYGREEN COSMETICS SUPPLIES CO.,LTD.]14 package rows20250316_2fe50634-5e21-b769-e063-6294a90a66ce.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85346-00185346-001-01, 85346-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
2fe50634-5e22-b769-e063-6294a90a66ce2fe50634-5e21-b769-e063-6294a90a66ce2025-03-13WarningsExact identifier
spl id: 2fe50634-5e22-b769-e063-6294a90a66ce
spl set id: 2fe50634-5e21-b769-e063-6294a90a66ce

Reported adverse events (FAERS/openFDA)#

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