FDA.reportPublic FDA data

Dr. Zenni Natural OrthodonticToothpaste

Manufacturer
Zeniton Co.,Ltd. | DONG IL PHARMS CO., LTD.
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:00

Label at a glance#

ProductDr. Zenni Natural OrthodonticToothpaste
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Indications and uses

■ Helps protect against cavities ■ Removal of plaque

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.75%

PURPOSE

OTC - PURPOSE SECTION

Anticavity

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

■ Helps protect against cavities
■ Removal of plaque

WARNINGS

WARNINGS SECTION

Keep out or reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D-Sorbitol Solution, Water, Silicon Dioxide, Concentrated Glycerin, Hydroxyapatite, Sodium Cocoyl Glutamate, Xanthangum, Red Wine Flavor, Xylitol, L-Menthol, Peppermint Oil, Aminocaproic Acid, Aluminum Chlorohydroxy Allantoinate, Grapefruit Seed Extract, Green Tea Extract, Chamomile Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Sodium Chloride, Tocopherol Acetate

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃)

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 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73029-0012-12023-01-30C16284748780-1f386c649-9c02-0266-e053-dadaa90a7c1ab4ada907-5d3a-31a3-e053-2a95a90a7ade

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73029-0012-1Dr. Zenni Natural OrthodonticToothpaste100 g in 1 TUBEPASTE, DENTIFRICE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73029-0012DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ZENITON CO.,LTD.]2Legacy NDC, 1 package rows20211229_b4ada907-5d3a-31a3-e053-2a95a90a7ade.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
73029-001273029-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
1e33c52b-0b9a-49b2-a71e-a30209094b5bb4ada907-5d3a-31a3-e053-2a95a90a7ade2021-12-28WarningsExact identifier
spl id: 1e33c52b-0b9a-49b2-a71e-a30209094b5b
spl set id: b4ada907-5d3a-31a3-e053-2a95a90a7ade

Reported adverse events (FAERS/openFDA)#

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