FDA.reportPublic FDA data

Chewpaste with Fluoride

Manufacturer
2557807 Ontario Inc
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:08

Label at a glance#

ProductChewpaste with Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Helps prevent tooth decay

Dosage and administration

Adults and children over 6 years of age: 1 tablet, 2 times per day • Do not swallow • Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally • Repeat every morning and night • Consult a healthcare professional before using on children under 6 years

Storage and handling

Store in a tightly closed container in a cool, dry place

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

0.25% Sodium fluoride (1.2mg)/tablet

PURPOSE:

OTC - PURPOSE SECTION

Dentifrice

USES:

INDICATIONS & USAGE SECTION

Helps prevent tooth decay

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 6 years of age: 1 tablet, 2 times per day • Do not swallow • Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally • Repeat every morning and night • Consult a healthcare professional before using on children under 6 years

STORAGE:

STORAGE AND HANDLING SECTION

Store in a tightly closed container in a cool, dry place

NON ACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Dicalcium phosphate, Kaolin, Xylitol, Erythritol, Magnesium stearate, Sodium lauryl sulfoacetate, Sodium bicarbonate, Mint flavour, Hydroxypropyl methylcellulose, Clay, Vanilla flavour, Eucalyptol, Xanthan gum, Citric acid, Menthol

WARNING:

WARNINGS SECTION

• If swallowed, call a poison control centre or get medical help right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

SPL UNCLASSIFIED SECTION

Minty Vanilla

Do not use if seal is broken

Made in Canada

Etee Reusables Toronto, ON, Canada, shopetee.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
81048-008-642022-01-28C16284748780-1d6a99b39-e7de-a426-e053-dadaa90af4c2etee Chewpaste Toothpaste with Fluoride
81048-008-922022-01-28C16284748780-1d6a99b39-e7de-a426-e053-dadaa90af4c2etee Chewpaste Toothpaste with Fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81048-008-64Chewpaste with Fluoride64 in 1 JARTABLET, CHEWABLE641
81048-008-92Chewpaste with Fluoride192 in 1 JARTABLET, CHEWABLE1921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81048-008CHEWPASTE WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [2557807 ONTARIO INC]1Legacy NDC, 2 package rows20210215_adb10d5c-9c0f-426a-815d-20a4e8c37a2d.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81048-00881048-008-64, 81048-008-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
KAOLIN24H4NWX5COIACT
XYLITOLVCQ006KQ1EIACT
ERYTHRITOLRA96B954X6IACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MINTFV98Z8GITPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
BENTONITEA3N5ZCN45CIACT
VANILLA BEANQ74T35078HIACT
EUCALYPTOLRV6J6604TKIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT

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
7be4d379-404b-4762-8ca9-5b8ef27a4fb3adb10d5c-9c0f-426a-815d-20a4e8c37a2d2020-11-17WarningsExact identifier
spl id: 7be4d379-404b-4762-8ca9-5b8ef27a4fb3
spl set id: adb10d5c-9c0f-426a-815d-20a4e8c37a2d

Reported adverse events (FAERS/openFDA)#

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