Tooth

Manufacturer
Henan Dailygreen Biotechnology Co. LTD
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:10

Label at a glance#

ProductTooth
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

- Adults and children 6 years of age and older: Chew 1 tablet until crushed. - Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician. - Spit out: Do not swallow the tablet. - Children under 6 years of age should be supervised when using this product.

Storage and handling

Store at 1-30 °℃ (33.8 - 86°F). Protect from excessive moisture.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.54mg (0.7mg fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

- Use this product only for brushing your teeth.

- Do not swallow the toothpaste tablets.

- Keep out of reach of children.

- Small tablets may be a choking hazard for children under 3 years old.

- Keep toothpaste away from pets.

- If you experience any irritation or sensitivity while using this product, discontinue use.

OTC - DO NOT USE SECTION

N/A

OTC - WHEN USING SECTION

n/a

OTC - STOP USE SECTION

If you experience any irritation or sensitivity while using this product, discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

- Adults and children 6 years of age and older: Chew 1 tablet until crushed.

- Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.

- Spit out: Do not swallow the tablet.

- Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

Store at 1-30 °℃ (33.8 - 86°F).

Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Silica, Tetrasodium pyrophosphate, Pyridoxine HCI (Vitamin B6), Sorbitol, Microcrystalline cellulose, Xylitol, Stevia rebaudiana extract, Sodium chloride, Hydroxypropyi cellulose, Xanthan gum, Sodium cocoyl glutamate, Sodium bicarbonate, Magnesium stearate, Hydroxyapatite, Tocopheryl acetate (Vitamin E), Sodium ascorbate (Vitamin C), Menthol, Flavor, Camellia sinensis leaf extract, Eucalyptus globulus leaf oil, Rosmarinus officinalis (Rosemary) leaf extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83861-002-0183861-002-0183861-002-0283861-002-0283861-002-0383861-002-0383861-002-0483861-002-04

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83861-002-012026-01-29C16284748780-149896155-b864-586f-e063-e6dba90add9083861-002
83861-002-022026-01-29C16284748780-149896155-b864-586f-e063-e6dba90add9083861-002
83861-002-032026-01-29C16284748780-149896155-b864-586f-e063-e6dba90add9083861-002
83861-002-042026-01-29C16284748780-149896155-b864-586f-e063-e6dba90add9083861-002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83861-002-01Tooth43.4 g in 1 BOXTABLET43.41
83861-002-02Tooth43.4 g in 1 BOXTABLET43.41
83861-002-03Tooth173.6 g in 1 BOXTABLET173.61
83861-002-04Tooth173.6 g in 1 BOXTABLET173.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83861-002TOOTH (TOOTHPASTE TABLETS) TABLET [HENAN DAILYGREEN BIOTECHNOLOGY CO. LTD]14 package rows20240928_2310c30d-8dc5-56a4-e063-6394a90a1a41.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83861-00283861-002-01, 83861-002-02, 83861-002-03, 83861-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
2310bd55-2d6a-d2a1-e063-6394a90a2e932310c30d-8dc5-56a4-e063-6394a90a1a412024-09-27WarningsExact identifier
spl id: 2310bd55-2d6a-d2a1-e063-6394a90a2e93
spl set id: 2310c30d-8dc5-56a4-e063-6394a90a1a41

Reported adverse events (FAERS/openFDA)#

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