FDA.reportPublic FDA data

First salt after rain gray salt toothpaste

Manufacturer
IMJACOMPANY.CO | DONG IL PHARMS CO., LTD.
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:00

Label at a glance#

ProductFirst salt after rain gray salt toothpaste
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

helps protect against cavities.

Dosage and administration

■ adults and children 2 years of age and older : brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician ■ children 2 to 6 years : use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) ■ children under 2 years : ask a dentist or physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CALCIUM CARBONATE 38.0%

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Glycerin, Sodium Lauryl Sulfate, PEG-32, Cellulose Gum, Sodium Saccharin, Mentha Piperita Oil, Silica, Titanium Dioxide, Sodium Benzoate, Sodium Chloride, Dicalcium Phosphate Dihydrate, Menthol, 6-Aminocaproic Acid, Alcloxa, Xylitol, Ascorbic Acid

PURPOSE

OTC - PURPOSE SECTION

Anti-carries

WARNINGS

WARNINGS SECTION

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

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 2 years of age and older : brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
■ children 2 to 6 years : use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
■ children under 2 years : ask a dentist or physician

Other Information

OTHER SAFETY INFORMATION

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83876-010-01First salt after rain gray salt toothpaste120 g in 1 TUBEPASTE, DENTIFRICE1201
83876-010-02First salt after rain gray salt toothpaste1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83876-010FIRST SALT AFTER RAIN GRAY SALT TOOTHPASTE (CALCIUM CARBONATE) PASTE, DENTIFRICE [IMJACOMPANY.CO]12 package rows20240112_2495eaca-e6cd-48e1-8f52-ab8dac233819.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83876-01083876-010-01, 83876-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIM
Sorbitol506T60A25RIACT
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
e11296ba-6e5d-4c1f-a8b7-df3275f439cb2495eaca-e6cd-48e1-8f52-ab8dac2338192024-01-11WarningsExact identifier
spl id: e11296ba-6e5d-4c1f-a8b7-df3275f439cb
spl set id: 2495eaca-e6cd-48e1-8f52-ab8dac233819

Reported adverse events (FAERS/openFDA)#

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