Go Smile

Manufacturer: Go Smile, Inc.
Effective date: 2023-11-15
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:02:14

Label at a glance#

ProductGo Smile MINT

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 2 years of age or older – Brush teeth thoroughly for 2 minutes at least twice a day preferably after each meal or as directed by a dentist or doctor. Children under 6 years of age – Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age – Consult a dentist or doctor

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age or older – Brush teeth thoroughly for 2 minutes at least twice a day preferably after each meal or as directed by a dentist or doctor.
Children under 6 years of age – Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age – Consult a dentist or doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, sodium ascorbyl phosphate, tocopherol, retinyl palmitate, aloe barbadensis leaf juice, flavor, sodium lauryl sulfate, sodium methyl cocoyl taurate, sodium saccharin, cellulose gum, titanium dioxide

USES

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (w/w)

WARNINGS

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

OTHER INFORMATION

OTHER SAFETY INFORMATION

STORE AT ROOM TEMPERATURE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Toothpaste_Box_Final_OL_Crop Dieline

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44873-008-00	2025-01-30	C162847	48780-1	2cef2736-967e-d83d-e063-dadaa90ab31f	GOSMILE (as PLD) - TOOTHPASTE, MINT (44873-008)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44873-008-00	Go SmileMINT	100 g in 1 TUBE	PASTE, DENTIFRICE	100		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44873-008	GO SMILE MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [GO SMILE, INC.]	9	Legacy NDC, 1 package rows	20231116_570187da-6747-4da8-b9e3-9a53d5dcdbc3.zip

Products#

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

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

Go Smile MINT
SODIUM FLUORIDE
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
TITANIUM DIOXIDE
SODIUM BENZOATE
SACCHARIN SODIUM
VALERIAN
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
44873-008	44873-008-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
VALERIAN	JWF5YAW3QW	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	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
0a33d2ce-d5a3-1f75-e063-6394a90a0d1b			570187da-6747-4da8-b9e3-9a53d5dcdbc3	2023-11-15	Warnings	Exact identifier spl id: 0a33d2ce-d5a3-1f75-e063-6394a90a0d1b spl set id: 570187da-6747-4da8-b9e3-9a53d5dcdbc3

Reported adverse events (FAERS/openFDA)#

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