Smiley Gripper

Manufacturer: Dr. Fresh, Inc.
Effective date: 2011-06-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:51:13

Label at a glance#

ProductSmiley Gripper

Active ingredientSODIUM FLUORIDE

Label structure12 sections

Indications and uses

Helps prevent cavities

Dosage and administration

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician. Do not swallow To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist

Contacts and useful links#

PhoneLabel contact1-866-373-7374

PhoneLabel contact1-714-690-1573

Websitewww.drfresh.com

www.drfresh.com

Websitewww.drfresh.co.uk

www.drfresh.co.uk

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Helps prevent cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician. Do not swallow

To minimize swallowing use a pea-sized amount in children under 6.

Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, flavor, sodium phosphate, xanthan gum, carbomer 956, sodium saccharin, titanium dioxide, blue no. 1

Comments? Questions?

OTC - QUESTIONS SECTION

Dr. Fresh Inc

Buena Park, CA 90620 USA

Toll Free: 1-866-DR-FRESH

Visit us at: www.drfresh.com

DESCRIPTION SECTION

Smiley Gripper
Crest has been shown to be an effective decay-preventative dentifrice that can be of significant value when used as directed in a conscientiously applied program of oral hygiene and regular professional care.
Council on Scientific Affairs - American Dental Association

This product contains no sugar, like all ADA Accepted toothpastes.

The Smiley Gripper toothbrush is specially designed to stick and stand on bathroom counters and sink to avoid contamination.

CAUTION/CHOKING HAZARD: This product is not a toy and should always be used with adult supervision. Not intended for children under 3 years of age. Do not let kids chew or pull apart rubber end.

Crest(R) toothpaste is a product of Procter and Gamble, Cincinnati, OH USA

Distributed by
Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada- Dr. Fresh Inc. Ontario Canada L7C2T4
268 Bath Road, Slough, Berkshire SL1 4DX

Questions? Comments? Toll Free:
1-866-373-7374 USA 1-714-690-1573

UK and IRL: +44(0)1753 725365
comments@drfresh.com
visit us online at

www.drfresh.com

www.drfresh.co.uk

Toothpaste and packaging Made in U.S.A.,
Toothbrush made in PRC

Smileguard and related trademarks, names, logos and patents are the property of Dr. Fresh, Inc. and are registered and/or used in the U.S. and countries around the world (c) 2011 Dr. Fresh, Inc. Patent Pending

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smiley Gripper

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brush and Cover Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brush and Cover Kit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64893-495-01	2021-09-28	C162847	48780-1	960f7f55-cef6-8e05-e053-dbdaa90a074a	Smiley Gripper
64893-495-01	2019-10-29	C162847	48780-1	960f7f55-cef6-8e05-e053-dbdaa90a074a	Smiley Gripper

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
PHOSPHATE ION	INACTIVE INGREDIENT	NK08V8K8HR	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Smiley Gripper
SODIUM FLUORIDE
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
PHOSPHATE ION
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE
XANTHAN GUM
SACCHARIN SODIUM
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64893-495	64893-495-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
PHOSPHATE ION	NK08V8K8HR	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
MICA	V8A1AW0880	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 250 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOLUTION / ORAL	27 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SYRUP / ORAL	1.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	CREAM / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	TABLET / ORAL	16 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SUSPENSION / ORAL	40 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / ORAL	10.35 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOLUTION / NASAL	1.89 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION, SOLUTION / INTRAMUSCULAR	0.14 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates

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
d4c52020-fa7c-4b0f-96b0-2525bb9ab6a8			9a7120c1-16ec-44ab-9bb3-bdd3f4ba592d	2021-09-27	Warnings	Exact identifier spl set id: 9a7120c1-16ec-44ab-9bb3-bdd3f4ba592d

Reported adverse events (FAERS/openFDA)#

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