Enamelon Preventive Treatment

Product NDC: 48783-500
11-digit product format: 487830500
Labeler code: 48783
Product ID: 48783-500_4847e624-6a03-7e43-e063-6394a90a5045
Type: HUMAN OTC DRUG
Nonproprietary name: stannous fluoride
Dosage form: GEL
Route: DENTAL
Labeler: Premier Dental Products Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-01
Substance: STANNOUS FLUORIDE
Active strength: .004 g/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Enamelon Preventive Treatment
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	.004 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237847	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04c3f178-7905-404d-9ac2-67c453287ddf	Available on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48783-500	ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]	7	Current NDC, Legacy NDC, 2 package rows	20241027_04c3f178-7905-404d-9ac2-67c453287ddf.zip

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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	3bba340e-2a62-3b04-41b5-0ed9c13adb13	2026-04-22	Warnings	Exact identifier application number: M021
EverSmile Squirt	SODIUM FLUORIDE 0.05%	Everbrands, Inc.	bc0ef174-2909-469a-b629-0eab4412bdfc	2026-04-20	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	41d6cc7a-0b87-e474-e063-6294a90ae995	2026-04-20	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf	2026-04-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	H E B	8d40f693-083c-4eb6-9da1-42675d757e0e	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: M021
Eversmile OrthoFoam Anticavity	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	9c12e792-94c8-4e29-9a54-e7e70aadade6	2026-04-16	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	6753b426-6d49-4438-a52f-c28e60a0e9d8	2026-04-16	Warnings	Exact identifier application number: M021
Osstem G Gum Health Care Tooth	SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8b4fc0-4c98-5e52-e063-6394a90af710	2026-04-15	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Enamel Strength	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	4f6b8851-c778-8abd-e063-6294a90aef4f	2026-04-14		Exact identifier application number: M021
Crest 3D White Stain Eraser Luxe Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6beb3b-2521-bfb7-e063-6394a90ad9ea	2026-04-14		Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6d11b2-5aa2-ab34-e063-6294a90ac0bc	2026-04-14	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Publix Super Markets, Inc.	cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	f0e84078-499f-4a5a-bcd2-23f57805de86	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Pro-Health Advanced Multi-Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1cfc5b61-c8e5-943d-e063-6394a90a890b	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Multi-Protection plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6f6299-f95f-2f0e-e063-6294a90a1641	2026-04-14	Warnings	Exact identifier application number: M021
Crest 3D White Strength Whitening Enamel Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f7125aa-3aa2-ca64-e063-6394a90a4cf3	2026-04-14	Warnings	Exact identifier application number: M021
Eversmile TheraFoam	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	57da2479-923a-45ec-8149-57b469b11637	2026-04-13	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Bacteria Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ce508-fe6e-4045-e063-6294a90ab3e2	2026-04-10	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	4f1d62ae-653e-3046-e063-6294a90abbf8	2026-04-10	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237847	stannous fluoride 0.4 % Oral Gel	PSN	04c3f178-7905-404d-9ac2-67c453287ddf	8
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	04c3f178-7905-404d-9ac2-67c453287ddf	8
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	04c3f178-7905-404d-9ac2-67c453287ddf	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48783-500-40	48783050040	1 TUBE in 1 CARTON (48783-500-40) / 113 g in 1 TUBE	1 tube	2014-01-01	0000-00-00	No	No	Current