Freshmint Premium Anticavity Gel - New World Imports, Inc

Manufacturer: New World Imports, Inc
Effective date: 2026-10-12
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: daily-update
Hydrated at: 2026-10-15 01:02:04

Label at a glance#

ProductFreshmint Premium Anticavity Gel

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist. Do not swallow. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount) Supervise children's brushing until capable of using without supervision Children under 2 years: consult a dentist or doctor

Label contents#

Full prescribing information#

OTC Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride - 0.243% (Fluoride ion content: 1100 ppm)

OTC Purpose

OTC - PURPOSE SECTION

Anticavity

Keep out of reach of Children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years & older:

Brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist.
Do not swallow.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount)
Supervise children's brushing until capable of using without supervision

Children under 2 years:

consult a dentist or doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Treated Water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Saccarin, Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue # 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CGADA Tube

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	INACTIVE INGREDIENT	B70850QPHR	1
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Freshmint Premium Anticavity Gel
Sodium Fluoride
FLUORIDE ION
SORBITOL
SILICON DIOXIDE
WATER
POLYETHYLENE GLYCOL 1600
SODIUM LAURYL SULFATE
GLYCERIN
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE
SODIUM BENZOATE
SODIUM PYROPHOSPHATE
FD&C BLUE NO. 1
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51824-046	51824-046-01, 51824-046-02, 51824-046-03, 51824-046-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL 1600	1212Z7S33A	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2026-09-08	daily-update	2026-09-11 03:02:26
6	2025-12-01	full-release	2026-06-01 01:19:00

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 2 · 85 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM PYROPHOSPHATE	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	PASTE / DENTAL	4.96 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	POWDER, FOR SUSPENSION / ORAL		330 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	PASTE / DENTAL	4.96 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	GRANULE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	CAPSULE, DELAYED RELEASE PELLETS / ORAL		11 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	GEL / DENTAL	5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	GEL / DENTAL	5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	PASTE / DENTAL	4.96 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	GRANULE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	GEL / DENTAL	5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	GRANULE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	PASTE / DENTAL	4.96 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	CAPSULE, DELAYED RELEASE PELLETS / ORAL		11 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	POWDER, FOR SUSPENSION / ORAL		330 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	PASTE / DENTAL	4.96 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	CAPSULE, DELAYED RELEASE PELLETS / ORAL		11 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	POWDER, FOR SUSPENSION / ORAL		330 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 10 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
Freshmint Premium Anticavity Gel	SODIUM FLUORIDE	New World Imports, Inc	dfe564c1-2097-431d-93f0-cf423f254248	2026-09-08	Warnings	Exact identifier ndc (package): 51824-046-03 ndc (package): 51824-046-04 ndc (package): 51824-046-01 ndc (package): 51824-046-02 ndc (product): 51824-046 ndc11 (package): 51824004603 ndc11 (package): 51824004602 ndc11 (package): 51824004604 ndc11 (package): 51824004601 spl set id: dfe564c1-2097-431d-93f0-cf423f254248

Reported adverse events (FAERS/openFDA)#

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