SuperSmile Professional

Manufacturer: ROBELL RESEARCH, INC. | Lornamead
Effective date: 2012-10-03
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 22:34:13

Label at a glance#

ProductSuperSmile Professional Whitening

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure10 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.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings:

WARNINGS SECTION

As with all fluoride toothpastes,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

children under 6 years old.

SPL UNCLASSIFIED SECTION

Directions:

DOSAGE & ADMINISTRATION SECTION

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist.

Directions:

INDICATIONS & USAGE SECTION

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 Phosphate Dihydrate, Sodium Bicarbonate, Calcium Carbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn Starch, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Methyl Paraben, Sodium Saccharin, Propyl Paraben

Questions:

OTC - QUESTIONS SECTION

1-800 -784 -SMILE

Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	7
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53567-0101-6	2020-01-31	C162847	48780-1	9d75b9d0-67c3-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53567-0101-6	SuperSmile ProfessionalWhitening	227 g in 1 TUBE	PASTE, DENTIFRICE	227		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53567-0101	SUPERSMILE PROFESSIONAL WHITENING (FLUORIDE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]	7	Legacy NDC, 1 package rows	20130110_43e5e8f9-1bb1-4154-b6a3-36af8c870c4d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	7
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	7
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	7
CALCIUM PEROXIDE	INACTIVE INGREDIENT	7FRO2ENO91	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	7
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	7
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	7
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	7
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	7
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	7
SODIUM LAURYL SULFOACETATE	INACTIVE INGREDIENT	D0Y70F2B9J	7
SODIUM PERBORATE	INACTIVE INGREDIENT	Y52BK1W96C	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	7

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

SuperSmile Professional Whitening
Fluoride
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
WATER
CALCIUM PEROXIDE
SODIUM PERBORATE
SODIUM BICARBONATE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CALCIUM CARBONATE
MAGNESIUM CARBONATE
STARCH, CORN
SACCHARIN
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFOACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53567-0101	53567-0101-6

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
WATER	059QF0KO0R	IACT
CALCIUM PEROXIDE	7FRO2ENO91	IACT
SODIUM PERBORATE	Y52BK1W96C	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
MAGNESIUM CARBONATE	0E53J927NA	IACT
STARCH, CORN	O8232NY3SJ	IACT
SACCHARIN	FST467XS7D	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM LAURYL SULFOACETATE	D0Y70F2B9J	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 6 · 347 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	TABLET, CHEWABLE / ORAL	100 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE / ORAL	401 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / AURICULAR (OTIC)	0.38 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	TABLET / ORAL		500 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET, CHEWABLE / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	CAPSULE, COATED PELLETS / ORAL	22.4 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 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
e123425c-cbac-47c2-b511-b07c4b14dee5			43e5e8f9-1bb1-4154-b6a3-36af8c870c4d	2012-10-03	Warnings	Exact identifier spl id: e123425c-cbac-47c2-b511-b07c4b14dee5 spl set id: 43e5e8f9-1bb1-4154-b6a3-36af8c870c4d

Reported adverse events (FAERS/openFDA)#

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