2080 Dentistry Night Repair

Manufacturer
Aekyung Industrial Co., Ltd. | Aekyung Ind. Co., Ltd._Chungyang Factory
Effective date
2017-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:43

Label at a glance#

Product2080 Dentistry Night Repair
Active ingredientSILICON DIOXIDE
Label structure14 sections

Storage and handling

Store in a sealed container at room temperature {1~30°C}

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients​Purpose
 Dental-Type Silica 15%Anticavity
 Calcium Glycerophosphate 0.13%Antisensitivity
 Cetylpyridinium Chloride 0.05%Antigingivitis
 Dipotassium Glycyrrhizinate 0.01%Antigingivitis

WARNINGS SECTION

Be careful not to swallow.  Rinse your mouth thoroughly after use.  Consult a doctor or dentist if gum problems occur after using this toothpaste.

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

DOSAGE & ADMINISTRATION 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.

INDICATIONS & USAGE SECTION

- Prevents and reduces tooth pain

- Maintains oral hygiene

- Removes bad breath

- Prevents dental caries

INSTRUCTIONS FOR USE SECTION

Directions: Apply suitable amount of toothpaste to toothbrush

OTC - DO NOT USE SECTION

Do not use for purpose other than brushing teeth.  Rinse with running water in the event that the toothpaste gets in the eye and consult a doctor for adverse reactions

STORAGE AND HANDLING SECTION

Store in a sealed container at room temperature {1~30°C}

OTC - QUESTIONS SECTION

Customer Center: 080-024-1357 (Nationwide Toll-Free)

We accept exchanges and returns in compliance with the Consumer Protection Act of the Fair Trade Commission

www.aekyung.co.kr

SPL UNCLASSIFIED SECTION

Manufacturer: Aekyung Co., Ltd

1547-9 Chungui-ro, Jeongsan-myeon, Cheongyanggun, Chungcheongnam-do, Korea

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Liquid Sorbitol (Non-crystalizing), Sodium N-Cocoyl-N-Methyl Taurate Solution, Polyethylene Glycol 1500, Cocamidopropyl Betain, Gellan Gum, Flavor, Calcium Chloride, Carboxymethylcellulose Sodium, Titanium Dioxide, Saccharin Sodium Hydrate, Xanthan Gum, Carrageenan, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box LabelBox Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67225-0010-12020-01-31C16284748780-19d75b9cf-de8c-f424-e053-dadaa90a57cedde82f7d-e6bb-49af-a4c8-979821b7436f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67225-0010-12080 Dentistry Night Repair100 g in 1 TUBEPASTE, DENTIFRICE1001
67225-0010-12080 Dentistry Night Repair1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67225-00102080 DENTISTRY NIGHT REPAIR (DENTAL TYPE SILICA (SILICON DIOXIDE), CALCIUM GLYCEROPHOSPHATE, CETYLPYRIDINIUM CHLORIDE, DIPOTASSIUM GLYCYRRHIZINATE) PASTE, DENTIFRICE [AEKYUNG INDUSTRIAL CO., LTD.]1Legacy NDC, 2 package rows20170203_dde82f7d-e6bb-49af-a4c8-979821b7436f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67225-001067225-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e0028b76-0496-4f8f-95ba-817bfc9164c1dde82f7d-e6bb-49af-a4c8-979821b7436f2017-02-03WarningsExact identifier
spl id: e0028b76-0496-4f8f-95ba-817bfc9164c1
spl set id: dde82f7d-e6bb-49af-a4c8-979821b7436f

Reported adverse events (FAERS/openFDA)#

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