TIDALOVE SMILE MORE ORAL CARE

Manufacturer
Paranmare | SUNGWON PHARMACEUTICAL CO., LTD
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:22

Label at a glance#

ProductTIDALOVE SMILE MORE ORAL CARE
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredients(in each tablet) purpose

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 1.54mg (0.7mg fluoride ion) anticavity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride(vitamin B6), D-sorbitol, microcrystalline cellulose, xylitol, enzymatically modified stevia, bamboo salt, hydroxypropylcellulose, xanthan gum, sodium cocoyl glutamate, sodium bicarbonate, magnesium stearate, hydroxyapatite, tocopherol acetate(vitamin E), sodium ascorbate (vitamin C), L-menthol, combined flavor, green tea extract, eucalyptus oil, rosemary extract

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities

OTC - WHEN USING 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - ASK DOCTOR SECTION

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

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

WARNINGS SECTION

Do not use it for anything other than brushing teeth, and be careful not to swallow it.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.Keep out of the reach of children.

Small tablets may be a chocking hazard for children under 3 years old.
Keep it away from the pets.
When using this product, if irritation or sensitivity occurs, discontinue use.

OTC - DO NOT USE SECTION

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

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION SECTION

Gently chew 1 tablet until it crushed. Brush teeth thoroughly,

INDICATIONS & USAGE 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

drug factsdrug factsdrug factsdrug facts

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82756-001-11TIDALOVE SMILE MORE ORAL CARE1.54 mg in 1 BAGTABLET1.544
82756-002-11TIDALOVE SMILE MORE ORAL CARE1.54 mg in 1 BAGTABLET1.544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82756-001TIDALOVE SMILE MORE ORAL CARE (SODIUM FLUORIDE TABLET) TABLET [PARANMARE]4Legacy NDC, 1 package rows20221209_e105f45c-2dc6-9ff3-e053-2a95a90a118d.zip
82756-002TIDALOVE SMILE MORE ORAL CARE (SODIUM FLUORIDE TABLET) TABLET [PARANMARE]4Legacy NDC, 1 package rows20221209_e105f45c-2dc6-9ff3-e053-2a95a90a118d.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82756-00182756-001-11
82756-00282756-002-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 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
ef56a2cf-43c0-5984-e053-2995a90a2980e105f45c-2dc6-9ff3-e053-2a95a90a118d2022-12-08WarningsExact identifier
spl id: ef56a2cf-43c0-5984-e053-2995a90a2980
spl set id: e105f45c-2dc6-9ff3-e053-2a95a90a118d

Reported adverse events (FAERS/openFDA)#

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