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

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 1 of 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	54bd43c9-489d-4e6b-9031-90ec0e3c4516	2026-09-01	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	53c344e9-49f5-48aa-8309-1e15f80b80a0	2026-09-01	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
TOTAL TP CLEAN MINT PST	STANNOUS FLUORIDE	Colgate-Palmolive Company	178d4535-fa57-4b53-b1f8-5c591f2ea9e7	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRY	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-04	Warnings	Exact identifier application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide Whitening	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	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