Supersmile

Manufacturer
Robell Research, Inc.
Effective date
2019-04-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:25:45

Label at a glance#

ProductSupersmile
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Monoflurophosphate

(0.14% w/v Fluoride Ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Dicalcium Phoshate Dihydrate, Sodium Bicarbonate, Calcium Carbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Flavor, Sodium Perborate, Corn Starch, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Sodium Saccharin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile®

With the whitening power of Calprox®

ICY MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

icy_minticy_mint

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q3
FLUORIDE IONACTIVE MOIETYQ80VPU408O3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK3
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO913
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3113
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP3
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NA3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO3
SODIUM LAURYL SULFOACETATEINACTIVE INGREDIENTD0Y70F2B9J3
SODIUM PERBORATEINACTIVE INGREDIENTY52BK1W96C3
SORBITOLINACTIVE INGREDIENT506T60A25R3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53567-092653567-0926-1, 53567-0926-3, 53567-0926-4, 53567-0926-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 · 257 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii candidate
10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, DELAYED RELEASE / ORAL2834 mgExact identifier — unii candidate
10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRASYNOVIAL0.1 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, COATED / ORAL3.2 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
34 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM CARBONATEMAGNESIUM CARBONATE0E53J927NACAPSULE / ORAL22.4 mgExact identifier — unii candidate
12 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, EXTENDED RELEASE / ORAL933 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, CHEWABLE / ORAL53 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM, SOLUBLE / BUCCAL47 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
34 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
86a723e2-d06d-5e0f-e053-2a91aa0a96af112c0e8e-6733-40dc-e054-00144ff8d46c2019-04-16WarningsExact identifier
spl id: 86a723e2-d06d-5e0f-e053-2a91aa0a96af
spl set id: 112c0e8e-6733-40dc-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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