FDA.reportPublic FDA data

mastikis gold

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:21

Label at a glance#

Productmastikis gold
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, Deionized Water, Glycerin, Mastic oil, Sodium Lauryl Sulfate, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Grapefruit Seed Extract, Xylitol, Steviol Glycoside, Hydroxyapatite, L-Menthol, Ascorbic Acid, Tocopherol Acetate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children.

OTC - PURPOSE SECTION

Anti-cavity

Anti-plaque

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Aids in the cleanness of teeth and protection of gum health

DOSAGE & ADMINISTRATION SECTION

Supervise children as necessary until capable of using without supervision.

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79814-001-022023-01-30C16284748780-1f386c64a-396a-0266-e053-dadaa90a7c1a79814-001_mastikis gold toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-001-01mastikis gold120 g in 1 TUBEPASTE, DENTIFRICE1201
79814-001-02mastikis gold1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-001MASTIKIS GOLD (SILICON DIOXIDE, AMINOCAPROIC ACID) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20200801_619bd3a9-6fcd-4ad7-9253-082aa341cf95.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79814-00179814-001-01, 79814-001-02

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
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CITRUS PARADISI SEED12F08874Y7IACT
XYLITOLVCQ006KQ1EIACT
STEVIOSIDE0YON5MXJ9PIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
LEVOMENTHOLBZ1R15MTK7IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
abc79e00-71e8-ce41-e053-2a95a90a3fe5619bd3a9-6fcd-4ad7-9253-082aa341cf952020-07-31WarningsExact identifier
spl id: abc79e00-71e8-ce41-e053-2a95a90a3fe5
spl set id: 619bd3a9-6fcd-4ad7-9253-082aa341cf95

Reported adverse events (FAERS/openFDA)#

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