Dr. Sheffield Fluoride Anticavity

Manufacturer: Sheffield Pharmaceuticals LLC
Effective date: 2019-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:49:37

Label at a glance#

ProductDr. Sheffield Fluoride Anticavity

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Indications and uses

Aids in the prevention of dental decay

Dosage and administration

Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Chlidren under 2 years of age: Conmsult a dentist...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride - 0.243%

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay

Warnings:

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
Supervise children as necessary until capable of using without supervision.
Chlidren under 2 years of age: Conmsult a dentist or doctor.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, PEG 6, Cellulose Gum, Flavor, Disodium Phosphate, Sodium Saccharin, Titanium Dioxide, and FD&C Blue No. 1

Principal Display Panel - 3 oz - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Sheffields NDC 11527-016-63

SHEAF-FIELD TM ADA Accepted

Cavity Protection

Sheffield FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 3 oz. ( 85g) MADE IN THE USA

Principal Display Panel - 3 oz - Carton

Principal Display Panel 3 oz -Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Sheffields NDC 11527-016-63

SHEAF-FIELD TM ADA Accepted

Cavity Protection

Sheffield FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 3 oz. ( 85g) MADE IN THE USA

Principal Display Panel 3 oz -Tube

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
PEG-6 STEARATE	INACTIVE INGREDIENT	8LQC57C6B0	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Dr. Sheffield Fluoride Anticavity
Fluoride Anticavity Toothpaste
SODIUM FLUORIDE
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
PEG-6 STEARATE
CARBOXYMETHYLCELLULOSE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SACCHARIN SODIUM
TITANIUM DIOXIDE
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11527-016	11527-016-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
PEG-6 STEARATE	8LQC57C6B0	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 · 328 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	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LOZENGE / TRANSMUCOSAL		112 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 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 PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / ORAL		66 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION/ DROPS / TOPICAL	0.14 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FILM COATED / ORAL	0.01 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 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
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, DELAYED RELEASE / ORAL		43 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, EXTENDED RELEASE / ORAL		207 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		8 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRA-ARTICULAR		28 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 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	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
faf48448-9bb6-4fbe-a231-d95373e70d37			6653e34d-9563-4292-bf37-b4e0f0e3b5cd	2022-09-22	Warnings	Exact identifier spl set id: 6653e34d-9563-4292-bf37-b4e0f0e3b5cd

Reported adverse events (FAERS/openFDA)#

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