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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Total Care Zero Alcohol Anticavity Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	4b594a6e-db1d-443b-bfa7-23ee15749f47	2024-12-19	Warnings	Exact identifier application number: M021
NewYork-Presbyterian Amenity	SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	4b307471-445d-4c51-a499-d074a8172f20	2024-12-17	Warnings	Exact identifier application number: M021
Colgate Anticavity	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive (Thailand) Limited - Branch	5bc0b430-6f68-4e52-a1da-de19136eaeac	2024-12-09	Warnings	Exact identifier application number: M021
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	03ec09f9-4281-9ccb-e063-6294a90aadd8	2024-12-01	Warnings	Exact identifier application number: M021
CURODONT PROTECT	STANNOUS FLUORIDE	CREDENTIS AG	03ec591c-68c3-a380-e063-6394a90a131a	2024-12-01	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Bubble Gum Blowout	SODIUM FLUORIDE	Chattem, Inc.	61f3a3e6-645b-4368-b1d5-7de1fc14542e	2024-12-01	Warnings	Exact identifier application number: M021
SparkleFresh Flouride Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Medline Industries, LP	1565528b-89f2-4c97-b294-15b6ebd3f80e	2024-11-26	Warnings	Exact identifier application number: M021
Rembrandt Intense Stain	SODIUM FLUORIDE	Ranir LLC	55dcd063-5661-35aa-e054-00144ff8d46c	2024-11-26	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	9f98913f-6754-4e1c-98cf-b89fe87750f8	2024-11-25	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	88f87f7a-5b2d-47c9-8830-6b88b4ddbb59	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	0c85d273-3b98-43ea-81ba-c90f70ab72f8	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	2a882210-49e6-4b9c-a2c6-eaa37b6514c3	2024-11-25	Warnings	Exact identifier application number: M021
Pepsodent Complete Care Original	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c6931cb-0ec9-41bb-b410-c355573aab57	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Strawberry Natural Fluoride	SODIUM FLUORIDE	Ranir LLC	8ee37955-fe1a-4964-ac29-d1d7dfb694cc	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	abdc7f79-5f87-4307-8ddd-e6281ac67a04	2024-11-20	Warnings	Exact identifier application number: M021
AIM Bubble Berry	SODIUM FLUORIDE	Church & Dwight Co., Inc.	c83ccdea-d75f-4084-853e-ed4bab9a12d4	2024-11-20	Warnings	Exact identifier application number: M021
AIM TARTAR CONTROL Plus Mouthwash and Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fc71c-d28e-4afa-e054-00144ff8d46c	2024-11-20	Warnings	Exact identifier application number: M021
Advance White Tartar Control Breath Freshening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	aa8be8f5-ba46-4b1b-afaa-58fddf8f8780	2024-11-20	Warnings	Exact identifier application number: M021
Enamel Defense	SODIUM FLUORIDE	Church & Dwight Co., Inc.	9e8f1ce9-b161-50db-e053-2995a90ad32b	2024-11-20	Warnings	Exact identifier application number: M021
Rembrandt Deeply White Plus Peroxide	SODIUM MONOFLUOROPHOSPHATE	Ranir LLC	bf7da007-ab9d-4631-bc28-6ca245fd6265	2024-11-20	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