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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	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