Go Smile

Manufacturer
Go Smile, Inc.
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:02:16

Label at a glance#

ProductGo Smile RELAX
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

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...

Label contents#

Full prescribing information#

PURPOSE

INDICATIONS & USAGE SECTION

ANTICAVITY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS: 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, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT.

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

​SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)

WARNINGS

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 PM 1.0 ozTube_V5_7_11GO SMiLE PM 1.0 ozTube_V5_7_11

GO SMiLE PM 3.5 ozTube_V4_7_11GO SMiLE PM 3.5 ozTube_V4_7_11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN6
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY6

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44873-007-00Go SmileRELAX100 g in 1 TUBEPASTE, DENTIFRICE1006
44873-007-01Go SmileRELAX28 g in 1 TUBEPASTE, DENTIFRICE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44873-007GO SMILE RELAX (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [GO SMILE, INC.]6Legacy NDC, 2 package rows20231116_c30b7f23-9b34-4137-94c5-d9fffb822c92.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44873-00744873-007-00, 44873-007-01

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0a33e170-e8a6-25a8-e063-6394a90addf5c30b7f23-9b34-4137-94c5-d9fffb822c922023-11-15WarningsExact identifier
spl id: 0a33e170-e8a6-25a8-e063-6394a90addf5
spl set id: c30b7f23-9b34-4137-94c5-d9fffb822c92

Reported adverse events (FAERS/openFDA)#

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