T-SERIES

Manufacturer: SUNGWON PHARMACEUTICAL CO., LTD.
Effective date: 2019-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:01:06

Label at a glance#

ProductT-SERIES

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

for oral use only

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc

PURPOSE

OTC - PURPOSE SECTION

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

■ Prevention of tartar deposition

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNING

WARNINGS SECTION

For oral use only
When using this product

■ This toothpaste has a 1,000 ppm fluoride content

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

USES

DOSAGE & ADMINISTRATION SECTION

for oral use only

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them

■ scrub softly as like doing massage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76058-001-01	2021-01-29	C162847	48780-1	ba0f9c33-481b-a910-e053-dadaa90a0b85	953e23ce-1c2f-103c-e053-2995a90a3947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76058-001-01	T-SERIES	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76058-001	T-SERIES (SODIUM FLUORIDE) TABLET [SUNGWON PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20191019_953e23ce-1c2f-103c-e053-2995a90a3947.zip

Products#

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

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

T-SERIES
sodium fluoride
SODIUM BICARBONATE
SORBITOL
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76058-001	76058-001-01

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
SODIUM BICARBONATE	8MDF5V39QO	IACT
SORBITOL	506T60A25R	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

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
953e0b57-a59f-d70a-e053-2995a90a586b			953e23ce-1c2f-103c-e053-2995a90a3947	2019-10-18	Warnings	Exact identifier spl id: 953e0b57-a59f-d70a-e053-2995a90a586b spl set id: 953e23ce-1c2f-103c-e053-2995a90a3947

Reported adverse events (FAERS/openFDA)#

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