SALTRAIN TOOTH

Manufacturer: K.Boeun Pharmaceutical Co.,Ltd.
Effective date: 2020-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:33:25

Label at a glance#

ProductSALTRAIN TOOTH

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Apply an appropriate amount to your toothbrush and brush your teeth by brushing

WARNINGS SECTION

Keep out of reach of children under 6 years old.

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

INACTIVE INGREDIENT SECTION

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1862485	sodium monofluorophosphate 0.4 % Toothpaste	PSN	1
1862485	sodium monofluorophosphate 0.004 MG/MG Toothpaste	SCD	1
1862485	sodium monofluorophosphate 0.4 % Toothpaste	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8d	Product name	9	20250103
e89c33e6-9224-49b0-4d80-05239f586f24	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
74724-0021-1	2025-01-30	C162847	48780-1	2cef2736-ae07-d83d-e063-dadaa90ab31f	b3cec2cd-6a67-68ca-e053-2995a90ad738

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
74724-0021-1	SALTRAIN TOOTH	100 g in 1 TUBE	PASTE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74724-0021	SALTRAIN TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [K.BOEUN PHARMACEUTICAL CO.,LTD.]	1	Legacy NDC, 1 package rows	20201112_b3cec2cd-6a67-68ca-e053-2995a90ad738.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

SALTRAIN TOOTH
Sodium Monofluorophosphate
XYLITOL
WATER
FLUORIDE ION
AMINOCAPROIC ACID
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
74724-0021	74724-0021-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
XYLITOL	VCQ006KQ1E	IACT
WATER	059QF0KO0R	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
AMINOCAPROIC ACID	U6F3787206	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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
b3cecaf6-4e27-7266-e053-2995a90a5da2			b3cec2cd-6a67-68ca-e053-2995a90ad738	2020-11-11	Warnings	Exact identifier spl id: b3cecaf6-4e27-7266-e053-2995a90a5da2 spl set id: b3cec2cd-6a67-68ca-e053-2995a90ad738

Reported adverse events (FAERS/openFDA)#

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