FDA.reportPublic FDA data

Fluoride Toothpaste Tablets

Manufacturer
Henan Dailygreen Trade Co.,Ltd.
Effective date
2021-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:48

Label at a glance#

ProductFluoride
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

1. Chew: Place tablet in mouth and chew for 5 seconds. 2. Hydrate: Use a wet brush to moisten the toothpaste in your mouth and brush teeth. 3. Brush: Brush for at least 30 seconds. Rinse and spit out thoroughly. Brush teeth, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)....

Storage and handling

Store in room temperature. Avoid direct sunlight. Shelf life: 3 years. Production Date: as shown in the packing Website: www.dailygreen.en.alibaba.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.145%

Purpose

OTC - PURPOSE SECTION

Anticaries

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

˙ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Chew: Place tablet in mouth and chew for 5 seconds.
2. Hydrate: Use a wet brush to moisten the toothpaste in your mouth and brush teeth.

3. Brush: Brush for at least 30 seconds. Rinse and spit out thoroughly. Brush teeth, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Other Information

STORAGE AND HANDLING SECTION

Store in room temperature. Avoid direct sunlight.

Shelf life: 3 years.

Production Date: as shown in the packing

Website: www.dailygreen.en.alibaba.com

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Xylitol, Erythritol, Natural Mint Flavor, Calcium Carbonate, SodiumCocoyl Isethionate, Sodium Bicarbonate, Laurel Extract, Cooling Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 tablets / glass bottle: NDC: 80143-001-01

62 tablets / glass bottle: NDC: 80143-001-02

120 tablets / glass bottle: NDC: 80143-001-03

glass bottleglass bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 tablets / paper tube: NDC: 80143-001-04

90 tablets / paper tube: NDC: 80143-001-05

120 tablets / paper tube: NDC: 80143-001-06

paper tubepaper tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 tablets / carton: NDC: 80143-001-07

60 tablets / carton: NDC: 80143-001-08

cartoncarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 tablets / bag: NDC: 80143-001-09

62 tablets / bag: NDC: 80143-001-10

120 tablets / bag: NDC: 80143-001-11

1000 tablets / bag: NDC: 80143-001-12

bagbag

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80143-001-012023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-022023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-032023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-042023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-052023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-062023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-072023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-082023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-092023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-102023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-112023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets
80143-001-122023-01-30C16284748780-1f386c649-ebcf-0266-e053-dadaa90a7c1aFluoride Toothpaste Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80143-001-01Fluoride60 in 1 BOTTLE, GLASSTABLET, CHEWABLE603
80143-001-02Fluoride62 in 1 BOTTLE, GLASSTABLET, CHEWABLE623
80143-001-03Fluoride120 in 1 BOTTLE, GLASSTABLET, CHEWABLE1203
80143-001-04Fluoride60 in 1 TUBETABLET, CHEWABLE603
80143-001-05Fluoride90 in 1 TUBETABLET, CHEWABLE903
80143-001-06Fluoride120 in 1 TUBETABLET, CHEWABLE1203
80143-001-07Fluoride30 in 1 CARTONTABLET, CHEWABLE303
80143-001-08Fluoride60 in 1 CARTONTABLET, CHEWABLE603
80143-001-09Fluoride2 in 1 BAGTABLET, CHEWABLE23
80143-001-10Fluoride62 in 1 BAGTABLET, CHEWABLE623
80143-001-11Fluoride120 in 1 BAGTABLET, CHEWABLE1203
80143-001-12Fluoride1000 in 1 BAGTABLET, CHEWABLE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80143-001FLUORIDE (TOOTHPASTE TABLETS) TABLET, CHEWABLE [HENAN DAILYGREEN TRADE CO.,LTD.]3Legacy NDC, 12 package rows20211220_ad447c9a-6f0f-7fef-e053-2995a90a055f.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
80143-00180143-001-01, 80143-001-02, 80143-001-03, 80143-001-04, 80143-001-05, 80143-001-06, 80143-001-07, 80143-001-08, 80143-001-09, 80143-001-10, 80143-001-11, 80143-001-12

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
OLEIC ACID2UMI9U37CPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM ISETHIONATE3R36J71C17IACT
ERYTHRITOLRA96B954X6IACT
RACEMENTHOLYS08XHA860IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MYRCENE3M39CZS25BIACT

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
d3882ed7-e342-0e8d-e053-2a95a90ac369ad447c9a-6f0f-7fef-e053-2995a90a055f2021-12-19WarningsExact identifier
spl id: d3882ed7-e342-0e8d-e053-2a95a90ac369
spl set id: ad447c9a-6f0f-7fef-e053-2995a90a055f

Reported adverse events (FAERS/openFDA)#

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