2080 K Original

Manufacturer: AK AMERICA | Aekyung Ind. Co., Ltd._Chungyang Factory
Effective date: 2017-04-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:49:39

Label at a glance#

Product2080 K Original

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Fluoride 0.22% (0.1% w/v fluoride)

OTC - PURPOSE SECTION

Purpose: anticavity

WARNINGS SECTION

Do not use this product for purposes other than those described on the label. In case of eye contact, rinse off immediately with water. If irritation persists, seek medical help.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age

OTC - STOP USE SECTION

Stop using this product and consult your dentist if irritation to gums, teeth, or oral mucosa occurs

INDICATIONS & USAGE SECTION

Do not swallow. Rinse mouth with water after brushing.

Children under 6 years:

- To minimize swallowing, use a pea-sized amount. Supervise brushing until good habits are established.

- If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

This toothpaste contains 1,000 ppm fluoride

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Liquid Sorbitor, Water, Silicon Dioxide, Polyethylene Glycol 1500, Sodium Lauryl Sulfate Flavor, Sodium Chloride, Sodium Carboxymethylcellulose, Saccharin Sodium Hydrate, Phosphoric Acid, Panthenol, Ginkgo Biloba Leaf Extract, Erythritol, Yellow#203, Blue#1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71401-0007-1	2020-01-31	C162847	48780-1	9d75b9d0-da20-f424-e053-dadaa90a57ce	cbc91185-b8ee-4b6c-9b8d-d8f7ec30b9b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71401-0007-1	2080 K Original	120 g in 1 TUBE	PASTE	120		1
71401-0007-1	2080 K Original	1 in 1 PACKAGE	PASTE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71401-0007	2080 K ORIGINAL (SODIUM FLUORIDE) PASTE [AK AMERICA]	1	Legacy NDC, 2 package rows	20170426_cbc91185-b8ee-4b6c-9b8d-d8f7ec30b9b5.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

2080 K Original
Sodium Fluoride
FLUORIDE ION
SORBITOL
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
SACCHARIN SODIUM
SILICON DIOXIDE
PHOSPHORIC ACID
WATER
PANTHENOL
POLYETHYLENE GLYCOL 1500
FD&C BLUE NO. 1
SODIUM CHLORIDE
GINKGO
ERYTHRITOL
D&C YELLOW NO. 10

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71401-0007	71401-0007-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
WATER	059QF0KO0R	IACT
PANTHENOL	WV9CM0O67Z	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
GINKGO	19FUJ2C58T	IACT
ERYTHRITOL	RA96B954X6	IACT
D&C YELLOW NO. 10	35SW5USQ3G	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
1442bcf2-3fd6-4e8b-ad9e-4773449fca39			cbc91185-b8ee-4b6c-9b8d-d8f7ec30b9b5	2017-04-26	Warnings	Exact identifier spl id: 1442bcf2-3fd6-4e8b-ad9e-4773449fca39 spl set id: cbc91185-b8ee-4b6c-9b8d-d8f7ec30b9b5

Reported adverse events (FAERS/openFDA)#

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