toothpowder

Manufacturer: Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd | Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Effective date: 2016-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:47:03

Label at a glance#

Producttoothpowder

Active ingredientSODIUM FLUORIDE

Label structure6 sections

Indications and uses

helps protect against cavities.

Dosage and administration

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children 2-6 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 a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%(0.1 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

Children 2-6 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 a physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

calcium carbonate,silica,mint falvour,sodium laryl sulfate ,sodium benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

$1$ 12

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51289-500-01	2020-01-31	C162847	48780-1	9d75b9d0-a4ec-f424-e053-dadaa90a57ce	Charm-Tex toothpowder
51289-500-02	2020-01-31	C162847	48780-1	9d75b9d0-a4ec-f424-e053-dadaa90a57ce	Charm-Tex toothpowder
51289-500-03	2020-01-31	C162847	48780-1	9d75b9d0-a4ec-f424-e053-dadaa90a57ce	Charm-Tex toothpowder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51289-500-01	toothpowder	250 in 1 CARTON	POWDER	250	1
51289-500-01	toothpowder	28 g in 1 BAG	POWDER	28	1
51289-500-02	toothpowder	57 g in 1 BAG	POWDER	57	1
51289-500-02	toothpowder	250 in 1 CARTON	POWDER	250	1
51289-500-03	toothpowder	250 in 1 CARTON	POWDER	250	1
51289-500-03	toothpowder	85 g in 1 BAG	POWDER	85	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51289-500	TOOTHPOWDER (SODIUM FLUORIDE) POWDER [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO.,LTD]	1	Legacy NDC, 6 package rows	20160909_3c1495eb-09e8-2665-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

toothpowder
Sodium Fluoride
CALCIUM CARBONATE
SODIUM SILICATE
MINT
SODIUM BENZOATE
FLUORIDE ION
SODIUM LAURYL SULFATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51289-500	51289-500-03, 51289-500-02, 51289-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
SODIUM SILICATE	IJF18F77L3	IACT
MINT	FV98Z8GITP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SODIUM LAURYL SULFATE	368GB5141J	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
3c1495d4-1cad-266b-e054-00144ff8d46c			3c1495eb-09e8-2665-e054-00144ff8d46c	2016-09-09	Warnings	Exact identifier spl id: 3c1495d4-1cad-266b-e054-00144ff8d46c spl set id: 3c1495eb-09e8-2665-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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