Plak Smacker GREAT WHITE SHARK ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

Manufacturer: Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date: 2018-01-06
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:54:00

Label at a glance#

ProductPlak Smacker Anti Cavity Fluoride

Active ingredientSODIUM FLUORIDE

Label structure6 sections

Indications and uses

help aids in the prevention of dental 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 doctor. Do not swallow to minimize swallowing use a peasized amount in children under 6 instruct children under 6 years oa age in good brushing and rinsing habits. supervise children as necessary until capable of useing without supervision

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%(0.14% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

help aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

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 doctor.

Do not swallow

to minimize swallowing use a peasized amount in children under 6

instruct children under 6 years oa age in good brushing and rinsing habits.

supervise children as necessary until capable of useing without supervision

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol,Water ,Hydreated silica,PEG1500,Sodium Lauryl Sulfate,Flavor ,Sodium Carboxy Methyl Cellulose ,Sodium Saccharin,Sodium Benzoate,Blue1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	3
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	3
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	3
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	3
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71035-600-01	2020-01-31	C162847	48780-1	9d75b9d0-9c31-f424-e053-dadaa90a57ce	Plak Smacker GREAT WHITE SHARK ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
71035-600-02	2020-01-31	C162847	48780-1	9d75b9d0-9c31-f424-e053-dadaa90a57ce	Plak Smacker GREAT WHITE SHARK ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71035-600-01	Plak Smacker Anti Cavity Fluoride	4 in 1 CARTON	PASTE	4	3
71035-600-01	Plak Smacker Anti Cavity Fluoride	144 in 1 BOX	PASTE	144	3
71035-600-02	Plak Smacker Anti Cavity Fluoride	12 in 1 BOX	PASTE	12	3
71035-600-02	Plak Smacker Anti Cavity Fluoride	6 in 1 CARTON	PASTE	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71035-600	PLAK SMACKER ANTI CAVITY FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]	3	Legacy NDC, 4 package rows	20180108_400d8228-dc47-4eee-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Plak Smacker Anti Cavity Fluoride
Sodium Fluoride
SORBITOL
HYDRATED SILICA
DISODIUM ETHYLENE DIMYRISTAMIDE PEG-15 DISULFATE
SACCHARIN SODIUM
SODIUM BENZOATE
WATER
DISODIUM CARBOXYMETHYLARSONATE
SODIUM LAURYL SULFATE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71035-600	71035-600-01, 71035-600-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
DISODIUM ETHYLENE DIMYRISTAMIDE PEG-15 DISULFATE	X2CDV8U82V	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
WATER	059QF0KO0R	IACT
DISODIUM CARBOXYMETHYLARSONATE	T9HTL93NB7	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

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
62175f7d-6bbd-2fb8-e053-2991aa0adb4b			400d8228-dc47-4eee-e054-00144ff8d46c	2018-01-06	Warnings	Exact identifier spl id: 62175f7d-6bbd-2fb8-e053-2991aa0adb4b spl set id: 400d8228-dc47-4eee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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