83525-001 Toothpaste Tablets

Manufacturer
HONG KONG DAILYGREEN TRADE CO., LIMITED
Effective date
2023-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:13

Label at a glance#

Producttoothpastetablets
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

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 is accidentally 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

If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

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

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.

Questions?

OTC - QUESTIONS SECTION

Call (619) 940-6502

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83525-001-01

83525-001-0183525-001-01

83525-001-11

83525-001-1183525-001-11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83525-001-012024-07-30C16284748780-11030e365-435e-111a-e063-dadaa90a10e283525-001 Toothpaste Tablets
83525-001-012024-01-30C16284748780-11030e365-435e-111a-e063-dadaa90a10e283525-001 Toothpaste Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83525-001-01toothpastetablets6 in 1 BOXTABLET61
83525-001-11toothpastetablets60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83525-001TOOTHPASTETABLETS (TOOTHPASTE TABLETS) TABLET [HONG KONG DAILYGREEN TRADE CO., LIMITED]12 package rows20230610_fdadeb0b-63d3-0510-e053-6394a90a2732.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
83525-00183525-001-11, 83525-001-01

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
fdadeb0b-63d4-0510-e053-6394a90a2732fdadeb0b-63d3-0510-e053-6394a90a27322023-06-09WarningsExact identifier
spl id: fdadeb0b-63d4-0510-e053-6394a90a2732
spl set id: fdadeb0b-63d3-0510-e053-6394a90a2732

Reported adverse events (FAERS/openFDA)#

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