FDA.reportPublic FDA data

Mastikis Mastic 24K

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:43

Label at a glance#

ProductMastikis Mastic 24K
Active ingredientSILICON DIOXIDE, AMINOCAPROIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aminocaproic Acid 0.1%
Silica 16%

INACTIVE INGREDIENT SECTION

D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Hydroxyapatite, Sodium Bicarbonate, Bamboo salt, Xylitol, Steviol Glycoside, L-Menthol, Grapefruit Seed Extract, Mastic Oil, Olive Oil, Phytonside flavour, Glycyrrhiza Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children.

OTC - PURPOSE SECTION

Anti-cavity

Anti-plaque

WARNINGS SECTION

Ask a dentist before use if you have

- bleeding or redness lasting more than 2 weeks pain, swelling, pus, losse teeth, or more spacing between teeth

- These may be signs of periodontitis, a serious form of gum disease

INDICATIONS & USAGE SECTION

- Brighter and healthier teeth and better oral hygiene

- Anti-caries, anti-plaque, anti--gingivitis

- Prevents periodontal and gum disease

DOSAGE & ADMINISTRATION SECTION

Brush teeth with a pea-sized amount

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMINOCAPROIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79814-003-022023-01-30C16284748780-1f386c64a-4299-0266-e053-dadaa90a7c1a79814-003_Mastikis Mastic 24K toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-003-01Mastikis Mastic 24K110 g in 1 TUBEPASTE, DENTIFRICE1101
79814-003-02Mastikis Mastic 24K1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-003MASTIKIS MASTIC 24K (SILICON DIOXIDE, AMINOCAPROIC ACID) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20200815_1e214194-59d8-43fc-b815-9ea6ae1e0388.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79814-00379814-003-01, 79814-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
SODIUM BICARBONATE8MDF5V39QOIACT
XYLITOLVCQ006KQ1EIACT
STEVIOSIDE0YON5MXJ9PIACT
LEVOMENTHOLBZ1R15MTK7IACT
CITRUS PARADISI SEED12F08874Y7IACT
OLIVE OIL6UYK2W1W1EIACT
LICORICE61ZBX54883IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
AMINOCAPROIC ACIDU6F3787206ACTIB

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
acda82a3-c85f-70d7-e053-2995a90a4fc61e214194-59d8-43fc-b815-9ea6ae1e03882020-08-14WarningsExact identifier
spl id: acda82a3-c85f-70d7-e053-2995a90a4fc6
spl set id: 1e214194-59d8-43fc-b815-9ea6ae1e0388

Reported adverse events (FAERS/openFDA)#

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