HYDROGEMToothpaste

Manufacturer: H2 biohealthcare Co.,Ltd
Effective date: 2023-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:02:28

Label at a glance#

ProductHYDROGEMToothpaste

Active ingredientCALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

calcium hydrogen phosphate hydrate

OTC - PURPOSE SECTION

■ Prevention of cavities, removal of bad breath, prevention of gum disease

■ Prevention of gingivitis and periodontitis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

WARNINGS SECTION

For dental use only

When using this product

■ top use and ask a dentist if oral irritation or tooth sensitivity occurs

■ Be careful not to swallow and rinse your mouth thoroughly after use.

■ If any abnormality occurs while using toothpaste, such as damage to the gums or inside of the mouth, stop using it immediately and consult a dentist.

INACTIVE INGREDIENT SECTION

L-menthol, glycerin, saccharin sodium hydrate, spearmint oil, xylitol, purified water, sodium carboxymethyl cellulose, cocamidopropyl betaine, propolis

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83811-0001-1	2025-01-30	C162847	48780-1	2cef2736-ad28-d83d-e063-dadaa90ab31f	0a8ad5fa-49cc-4576-e063-6394a90a5d13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83811-0001-1	HYDROGEMToothpaste	150 g in 1 TUBE	PASTE, DENTIFRICE	150		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83811-0001	HYDROGEMTOOTHPASTE (CALCIUM HYDROGEN PHOSPHATE HYDRATE) PASTE, DENTIFRICE [H2 BIOHEALTHCARE CO.,LTD]	1	1 package rows	20231121_0a8ad5fa-49cc-4576-e063-6394a90a5d13.zip

Products#

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

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

HYDROGEMToothpaste
calcium hydrogen phosphate hydrate
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
XYLITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83811-0001	83811-0001-1

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
Name	UNII	Kind
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	ACTIB
XYLITOL	VCQ006KQ1E	IACT
WATER	059QF0KO0R	IACT

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
0a8abb63-d312-2f26-e063-6294a90a7896			0a8ad5fa-49cc-4576-e063-6394a90a5d13	2023-11-19	Warnings	Exact identifier spl id: 0a8abb63-d312-2f26-e063-6294a90a7896 spl set id: 0a8ad5fa-49cc-4576-e063-6394a90a5d13

Reported adverse events (FAERS/openFDA)#

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