Enamelon Gel

Manufacturer: Premier Dental Products Company
Effective date: 2026-01-13
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:32:23

Label at a glance#

ProductEnamelon Preventive Treatment

Active ingredientSTANNOUS FLUORIDE

Label structure11 sections

Indications and uses

Aids in the prevention of cavities Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact Helps prevent gingivitis Helps interfere with the harmful effects of plaque associated with gingivitis

Dosage and administration

Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise childre...

Contacts and useful links#

PhoneLabel contact1-888-670-6100

Websitewww.premusa.com

www.premusa.com

Websitewww.enamelon.com

www.enamelon.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.40% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity/Sensitivity Relief/Antigingivitis

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Helps prevent gingivitis
Helps interfere with the harmful effects of plaque associated with gingivitis

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Other information

SPL UNCLASSIFIED SECTION

This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Do not use if foil seal is broken or missing
Keep tightly closed when not in use
Store at controlled room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-888-670-6100
Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

United States Patent Numbers: US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

Ultramulsion® is a registered trademark of WhiteHill Oral Technologies, Inc.

Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth

Relieves the discomfort of dry mouth tissues
Non-irritating to patients with dry mouth
Optimized with calcium and phosphate ions
No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes

Distributed by:

Premier ^® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007285 www.enamelon.com

NDC 48783-500-40 021665 Rev4 SP

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRENGTHEN YOUR SMILE!

ACP ^TM Enamel Therapy

Premier ^®

Enamelon ^®

Preventive Treatment Gel

NET WT 4.0 OZ (113 g)

SENSITIVITY & DRY MOUTH

Clean Mint

HYDRAMULSION ^®

Enamelon Gel Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
237847	stannous fluoride 0.4 % Oral Gel	PSN	8
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	8
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
48783-500-40	2023-02-01	C162847	48780-1	f386c64a-0636-0266-e053-dadaa90a7c1a	Enamelon Gel
48783-500-40	2023-01-30	C162847	48780-1	f386c64a-0636-0266-e053-dadaa90a7c1a	Enamelon Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48783-500-40	Enamelon Preventive Treatment	113 g in 1 TUBE	GEL	113		8
48783-500-40	Enamelon Preventive Treatment	1 in 1 CARTON	GEL	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	2
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)	INACTIVE INGREDIENT	5216H1HX5F	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
LAUROYL SARCOSINE	INACTIVE INGREDIENT	LIJ19P3L6F	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2

Products#

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

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

Enamelon Preventive Treatment
stannous fluoride
ACESULFAME POTASSIUM
CALCIUM SULFATE
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)
COCAMIDOPROPYL BETAINE
DIMETHICONE
GLYCERIN
LAUROYL SARCOSINE
SODIUM PHOSPHATE, MONOBASIC
POLOXAMER 407
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SUCRALOSE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48783-500	48783-500-40

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
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CALCIUM SULFATE	WAT0DDB505	IACT
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)	5216H1HX5F	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERIN	PDC6A3C0OX	IACT
LAUROYL SARCOSINE	LIJ19P3L6F	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
STANNOUS FLUORIDE	3FTR44B32Q	ACTIM

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 2 · 96 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GUM, CHEWING / BUCCAL		70 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	0.22 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / PERIODONTAL	155 mg		Exact identifier — unii+dosage form 6 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	CAPSULE, EXTENDED RELEASE / ORAL	1.66 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	0.22 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	CAPSULE, EXTENDED RELEASE / ORAL	1.66 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / OPHTHALMIC		1 mg	Exact identifier — unii+dosage form 6 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET, EXTENDED RELEASE / ORAL	235 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET, COATED / ORAL	170 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / DENTAL	0.12 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	CAPSULE / ORAL	141.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET, EXTENDED RELEASE / ORAL	235 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / DENTAL	0.12 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / PERIODONTAL	155 mg		Exact identifier — unii+dosage form 6 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 44 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
Enamelon Preventive Treatment	STANNOUS FLUORIDE	Premier Dental Products Company	04c3f178-7905-404d-9ac2-67c453287ddf	2026-01-13	Warnings	Exact identifier ndc (package): 48783-500-40 ndc (product): 48783-500 ndc11 (package): 48783050040 spl id: 4847e624-6a03-7e43-e063-6394a90a5045 spl set id: 04c3f178-7905-404d-9ac2-67c453287ddf

Reported adverse events (FAERS/openFDA)#

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