ALEGRIA

Manufacturer
Seowangmo corporation
Effective date
2016-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:10

Label at a glance#

ProductALEGRIA
Active ingredientSodium Monofluorophosphate
Label structure8 sections

Dosage and administration

Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate 0.76%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: D-Sorbitol Solution, Silicon Dioxide, Dentaltype silica, Polyethylene Glycol 1500, Glycerin, Sodium Lauryl Sulfate, Carboxymethylcellulose Sodium, Sodium Benzoate, Allantonie Chlorohydroxy Aluminum, Aminocaproic Acid, Xylitol, Saccharin Sodium Hydrate, Licorice Extract, Sophora Extract, Aloevera Gel, Peppermint Oil, L-Menthol, Anethole, Carvone, Mica, Silver foil, Purified Water

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Use

INDICATIONS & USAGE SECTION

Use: Aids in the prevention of dental cavities

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809328358457GTIN-13: 8809328358457
EAN-13: 8809328358457
GTIN storage (14 digits): 08809328358457
alegria carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70406-010-012020-01-31C16284748780-19d75b9d1-0e64-f424-e053-dadaa90a57ce431be04b-d6a5-4f87-897c-3cfac0e76c5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70406-010-01ALEGRIA130 g in 1 CARTONPASTE, DENTIFRICE1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70406-010ALEGRIA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SEOWANGMO CORPORATION]1Legacy NDC, 1 package rows20160225_431be04b-d6a5-4f87-897c-3cfac0e76c5d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70406-01070406-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
7eb40ff3-ee72-4d3f-bd69-f3d5f30cf10c431be04b-d6a5-4f87-897c-3cfac0e76c5d2016-02-25WarningsExact identifier
spl id: 7eb40ff3-ee72-4d3f-bd69-f3d5f30cf10c
spl set id: 431be04b-d6a5-4f87-897c-3cfac0e76c5d

Reported adverse events (FAERS/openFDA)#

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