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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Kids Space Jam Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	54cbfb09-8fd7-ef08-99fd-14fc019c81ff	2024-11-14	Warnings	Exact identifier application number: M021
Colgate Kids Llama Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive	a7b02cb2-cfb3-7b35-42da-7924d156dcc3	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	COLGATE PALMOLIVE COMPANY	b6ca4ec7-5087-4693-82b7-199b44d7f931	2024-11-13	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Teeth Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	06e2de03-4a58-3de0-e063-6294a90a5857	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	ee9a962d-83c7-4b13-bff6-140e48785e8a	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield	SODIUM FLUORIDE	Kenvue Brands LLC	d69d2e0d-a3e3-4d95-992d-c0c59172b3a5	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast	SODIUM FLUORIDE	Kenvue Brands LLC	f09f334b-709c-473e-b91e-3f31480ceb90	2024-11-11	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	2697fa68-b991-ab09-e063-6394a90aec4c	2024-11-01	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	2698d6d8-051b-6c10-e063-6394a90a9418	2024-11-01	Warnings	Exact identifier application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)	SODIUM FLUORIDE	MADE BY DENTISTS INC	263c448b-728f-4370-bcdb-148d614d9b34	2024-10-30	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	17f589e9-f4ba-46d3-a345-db38f9a9067d	2024-10-17	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Wild Watermelon	SODIUM FLUORIDE	Chattem, Inc.	8d7faeab-ac70-472a-acbb-de67493718ce	2024-10-16	Warnings	Exact identifier application number: M021
Rexall Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	Old East Main CO.	691c9638-75d2-4e53-bec4-2eafacd7216c	2024-10-14	Warnings	Exact identifier application number: M021
Rexall Travel Toothbrush and Tooth-paste	SODIUM MONOFLUOROPHOSPHATE	Old East Main CO.	1bfba18b-1418-4c39-b666-96fa0674cc70	2024-10-14	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	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