FDA.reportPublic FDA data

2080 Dentistry Night Fresh

Manufacturer
Aekyung Industrial Co., Ltd. | Aekyung Ind. Co., Ltd._Chungyang Factory
Effective date
2017-02-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:43

Label at a glance#

Product2080 Dentistry Night Fresh
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
 Zinc Citrate, trihydrate 0.5%Anti Oral Malodor
 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

- Removes bad breath

- Maintains oral health

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), Glycerin, Polyethylene Glycol 1500, Sodium Alginate, Trisodium Citrate, Saccharin Sodium Hydrate, Cocamidopropyl Betain, Sodium Lauryl Sulfate, Sodium N-Cocoyl-N-Methyl Taurate Solution, Titanium Dioxide, Thymus Vulgaris (Thyme) Leaf Extract, Cymbopogon Citratus Extract, Pelargonium Graveolens Extract, Cinnamonium Zeylanicum Bark Extract, Foenlculum Vulgare (Fennel) Seed Extract, Rosemarinus Officinalis (Rosemary) Leaf Extract, Eugenia Caryphyllus (Clove) Flower Extract, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box LabelBox Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67225-0009-12020-01-31C16284748780-19d75b9cf-de8f-f424-e053-dadaa90a57cee2263f8a-c354-4a3d-8e06-f1f3bbdef79f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67225-0009-12080 Dentistry Night Fresh1 in 1 CARTONPASTE, DENTIFRICE12
67225-0009-12080 Dentistry Night Fresh100 g in 1 TUBEPASTE, DENTIFRICE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67225-00092080 DENTISTRY NIGHT FRESH (DENTAL TYPE SILICA (SILICON DIOXIDE), ZINC CITRATE, TRIHYDRATE, CETYLPYRIDINIUM CHLORIDE, DIPOTASSIUM GLYCYRRHIZINATE) PASTE, DENTIFRICE [AEKYUNG INDUSTRIAL CO., LTD.]2Legacy NDC, 2 package rows20170203_e2263f8a-c354-4a3d-8e06-f1f3bbdef79f.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67225-000967225-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
ZINC CITRATE TRIHYDRATEGNM26GAX7RIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
THYMUS VULGARIS LEAFGRX3499643IACT
CYMBOPOGON CITRATUS WHOLE6AE8LT94NGIACT
PELARGONIUM GRAVEOLENS WHOLE0E553RP62FIACT
CINNAMON BARK OILXE54U569ECIACT
FENNEL SEEDG3QC02NIE6IACT
ROSEMARYIJ67X351P9IACT
CLOVEK48IKT5321IACT
WATER059QF0KO0RIACT

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
5b63c38f-b307-40f1-8d85-b0365a4de261e2263f8a-c354-4a3d-8e06-f1f3bbdef79f2017-02-03WarningsExact identifier
spl id: 5b63c38f-b307-40f1-8d85-b0365a4de261
spl set id: e2263f8a-c354-4a3d-8e06-f1f3bbdef79f

Reported adverse events (FAERS/openFDA)#

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