Tooth

Manufacturer
Henan Dailygreen Biotechnology Co. LTD
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:59

Label at a glance#

ProductTooth
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

• Adults and children 6 years of age and older; Chew tablet briefly and brush thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet. • Supervise children under 6 years of age for brushing and rinsing.

Storage and handling

Store at 25-30*C (68-77*F). Protect from excessive moisture.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.925% (1445ppm w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

When using this product, if irritation or sensitivity occurs, discontinue use.

OTC - DO NOT USE SECTION

N/A

OTC - WHEN USING SECTION

When using this product, if irritation or sensitivity occurs, discontinue use.

OTC - STOP USE SECTION

n/a

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 6 years of age and older; Chew tablet briefly and brush thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet.

• Supervise children under 6 years of age for brushing and rinsing.

Other Information

STORAGE AND HANDLING SECTION

Store at 25-30*C (68-77*F). Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Xylitol, Sodium Cocoyl Isethionate (made from coconut), Microcrystalline Cellulose, Calcium Carbonate, Sodium Bicarbonate, Erythritol, Natural Mint, Sodium Fluoride, Guar Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83861-003-0183861-003-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83861-003-01Tooth180 in 1 BAGTABLET1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83861-003TOOTH (TOOTHPASTE TABLETS) TABLET [HENAN DAILYGREEN BIOTECHNOLOGY CO. LTD]11 package rows20241121_27425b6b-e8d6-0cb2-e063-6294a90aafbb.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83861-00383861-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
27422542-250c-3793-e063-6294a90a1a7527425b6b-e8d6-0cb2-e063-6294a90aafbb2024-11-19WarningsExact identifier
spl id: 27422542-250c-3793-e063-6294a90a1a75
spl set id: 27425b6b-e8d6-0cb2-e063-6294a90aafbb