GO SMILE LUXURY

Manufacturer: Go Smile, Inc.
Effective date: 2023-11-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:02:14

Label at a glance#

ProductGO SMILE LUXURY AM

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 AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSA...

Storage and handling

STORE AT ROOM TEMPERATURE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

USES

INDICATIONS & USAGE SECTION

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

WARNINGS

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 AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION.
CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE.

WARNINGS SECTION

IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GO SMiLE AM 3.5 ozTube_V4_7_11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	4
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44873-106-11	2025-01-30	C162847	48780-1	2cef2736-7ab7-d83d-e063-dadaa90ab31f	GOSMILE (as PLD) - LUXURY TOOTHPASTE, AM (44873-106)
44873-106-13	2025-01-30	C162847	48780-1	2cef2736-7ab7-d83d-e063-dadaa90ab31f	GOSMILE (as PLD) - LUXURY TOOTHPASTE, AM (44873-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44873-106-11	GO SMILE LUXURYAM	28 g in 1 TUBE	PASTE, DENTIFRICE	28		4
44873-106-13	GO SMILE LUXURYAM	100 g in 1 TUBE	PASTE, DENTIFRICE	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44873-106	GO SMILE LUXURY AM (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [GO SMILE, INC.]	4	Legacy NDC, 2 package rows	20231116_68f24abb-19b0-4dbd-aac0-9fd6dada1531.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

GO SMILE LUXURY AM
SODIUM MONOFLUOROPHOSPHATE
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE
TITANIUM DIOXIDE
SODIUM BENZOATE
SACCHARIN SODIUM
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
44873-106	44873-106-13, 44873-106-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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	05JZI7B19X	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	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
0a33e794-1f0d-2717-e063-6394a90a2c0b			68f24abb-19b0-4dbd-aac0-9fd6dada1531	2023-11-15	Warnings	Exact identifier spl id: 0a33e794-1f0d-2717-e063-6394a90a2c0b spl set id: 68f24abb-19b0-4dbd-aac0-9fd6dada1531

Reported adverse events (FAERS/openFDA)#

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