PremierPro Fluoride Tooth

Manufacturer: SVS, LLC (DBA S2S Global)
Effective date: 2015-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:41:24

Label at a glance#

ProductPremierPro Fluoride Tooth

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate (0.76%)

OTC - PURPOSE SECTION

Purpose: Anticavity

INDICATIONS & USAGE SECTION

Uses: Aids in the prevention of dental cavities

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age

OTC - ASK DOCTOR SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or physician.

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Tetrasodium Diphosphate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69392-001-01	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-02	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-03	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-04	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-05	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-06	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-07	2020-01-31	C162847	48780-1	9d75b9d0-01e4-f424-e053-dadaa90a57ce	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69392-001-01	PremierPro Fluoride Tooth	14 g in 1 TUBE	PASTE, DENTIFRICE	14	2
69392-001-02	PremierPro Fluoride Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	2
69392-001-03	PremierPro Fluoride Tooth	42 g in 1 TUBE	PASTE, DENTIFRICE	42	2
69392-001-04	PremierPro Fluoride Tooth	78 g in 1 TUBE	PASTE, DENTIFRICE	78	2
69392-001-05	PremierPro Fluoride Tooth	85 g in 1 TUBE	PASTE, DENTIFRICE	85	2
69392-001-06	PremierPro Fluoride Tooth	130 g in 1 TUBE	PASTE, DENTIFRICE	130	2
69392-001-07	PremierPro Fluoride Tooth	198 g in 1 TUBE	PASTE, DENTIFRICE	198	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69392-001	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2	Legacy NDC, 7 package rows	20150120_7faa8f2c-c583-4a3a-9fd7-c48a439bce5d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)	INACTIVE INGREDIENT	99H65D77XY	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

PremierPro Fluoride Tooth
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
WATER
SORBITOL
CALCIUM CARBONATE
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)
SODIUM LAURYL SULFATE
GLYCERIN
HYDRATED SILICA
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM PYROPHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69392-001	69392-001-01, 69392-001-02, 69392-001-03, 69392-001-04, 69392-001-05, 69392-001-06, 69392-001-07

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
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)	99H65D77XY	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	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 5 · 248 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM PYROPHOSPHATE	SODIUM PYROPHOSPHATE	O352864B8Z	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / RESPIRATORY (INHALATION)	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 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
946328f8-56db-4928-b767-30f65e8114fc			7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2015-01-19	Warnings	Exact identifier spl id: 946328f8-56db-4928-b767-30f65e8114fc spl set id: 7faa8f2c-c583-4a3a-9fd7-c48a439bce5d

Reported adverse events (FAERS/openFDA)#

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