K-MOM Baby Tooth

Manufacturer: MOTHER-K CO.,LTD | KMPHARMACEUTICAL Co.,Ltd.
Effective date: 2019-11-26
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:01:42

Label at a glance#

ProductK-MOM Baby Tooth

Active ingredientPOLOXAMER 407

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Poloxamer 407, Simethicone

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Use as small amount as a grain of rice.

WARNINGS SECTION

Keep away from infants.

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Xylitol, Stevioside, Cellulose Gum, Xanthan Gum, Potassium Sorbate, Etc.

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73429-0002-1	2022-07-29	C162847	48780-1	e4f33bdf-a0aa-d8a0-e053-dadaa90a6e4e	96a6cee3-4601-a5f8-e053-2995a90ac4df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73429-0002-1	K-MOM Baby Tooth	30 g in 1 TUBE	PASTE, DENTIFRICE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73429-0002	K-MOM BABY TOOTH (SIMETHICONE, POLOXAMER 407) PASTE, DENTIFRICE [MOTHER-K CO.,LTD]	3	Legacy NDC, 1 package rows	20191127_96a6cee3-4601-a5f8-e053-2995a90ac4df.zip

Products#

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

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

K-MOM Baby Tooth
Simethicone, Poloxamer 407
POLOXAMER 407
XYLITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73429-0002	73429-0002-1

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
Name	UNII	Kind
POLOXAMER 407	TUF2IVW3M2	ACTIB
XYLITOL	VCQ006KQ1E	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
984c119b-0acf-672a-e053-2a95a90af088			96a6cee3-4601-a5f8-e053-2995a90ac4df	2019-11-26	Warnings	Exact identifier spl id: 984c119b-0acf-672a-e053-2a95a90af088 spl set id: 96a6cee3-4601-a5f8-e053-2995a90ac4df

Reported adverse events (FAERS/openFDA)#

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