ORAL PROJEQT O1 TOOTHPASTETABLETS

Manufacturer: Sungwon Pharmaceutical Co., Ltd.
Effective date: 2022-08-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:50:30

Label at a glance#

ProductORAL PROJEQT O1 TOOTHPASTETABLETS

Active ingredientSODIUM FLUORIDE, SILICON DIOXIDE, SODIUM PYROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

for oral use only

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

PURPOSE

OTC - PURPOSE SECTION

Helps protect against cavities and freshen breath.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNING

WARNINGS SECTION

Keep out of reach of children Under 6 years of age.
If more than used for brushing is accidentally swallowed, get
medical help or contact a Poison Control Center immediately.
This toothpaste contains 1000ppm of fluorine.
If children under 6 years of age swallowed an over dose, get
medical help or contact a Poison Control Center immediately.

USES

DOSAGE & ADMINISTRATION SECTION

for oral use only

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

Adults and children 6 years of age and older

Literally chew a tablet then brush teeeth thoroughly,
preferably after each meal or at least twice a day, every day,
or as directed by a dentist or physician.
DO NOT swallow a tablet.
Children under 6 years of age: Consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PYRIDOXINE Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76058-500-01	2024-01-30	C162847	48780-1	0191ceaa-6b66-198a-e063-dbdaa90aec3e	e6de7e8a-08c8-962f-e053-2995a90aee46
76058-500-01	2023-12-28	C162847	48780-1	0191ceaa-6b66-198a-e063-dbdaa90aec3e	e6de7e8a-08c8-962f-e053-2995a90aee46
76058-500-01	2023-07-28	C162847	48780-1	0191ceaa-6b66-198a-e063-dbdaa90aec3e	e6de7e8a-08c8-962f-e053-2995a90aee46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76058-500-01	ORAL PROJEQT O1 TOOTHPASTETABLETS	62 in 1 BOTTLE, GLASS	TABLET	62		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76058-500	ORAL PROJEQT O1 TOOTHPASTETABLETS (SODIUM FLUORIDE) TABLET [SUNGWON PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20220824_e6de7e8a-08c8-962f-e053-2995a90aee46.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

ORAL PROJEQT O1 TOOTHPASTETABLETS
sodium fluoride
XYLITOL
SORBITOL
FLUORIDE ION
SILICON DIOXIDE
SODIUM PYROPHOSPHATE
PYROPHOSPHORIC ACID
PYRIDOXINE HYDROCHLORIDE
PYRIDOXINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76058-500	76058-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
XYLITOL	VCQ006KQ1E	IACT
SORBITOL	506T60A25R	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SILICON DIOXIDE	ETJ7Z6XBU4	ACTIB
SODIUM PYROPHOSPHATE	O352864B8Z	ACTIB
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e6de7e90-4789-18dc-e053-2995a90a63d5			e6de7e8a-08c8-962f-e053-2995a90aee46	2022-08-22	Warnings	Exact identifier spl id: e6de7e90-4789-18dc-e053-2995a90a63d5 spl set id: e6de7e8a-08c8-962f-e053-2995a90aee46

Reported adverse events (FAERS/openFDA)#

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