Enamelon

Product NDC: 48783-520
11-digit product format: 487830520
Labeler code: 48783
Product ID: 48783-520_4847e71b-2083-917b-e063-6394a90a2df0
Type: HUMAN OTC DRUG
Nonproprietary name: stannous fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Premier Dental Products Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-01
Substance: STANNOUS FLUORIDE
Active strength: .00454 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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	.00454 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
416784	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
1626375a-f78b-4192-b7f3-ca932acab7fb	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
48783-520-08	2023-02-01	Enamelon Paste
48783-520-43	2023-02-01	Enamelon Paste
48783-520-08	2023-01-30	Enamelon Paste
48783-520-43	2023-01-30	Enamelon Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48783-520-43	Enamelon	122 g in 1 TUBE	PASTE, DENTIFRICE	122		7
48783-520-43	Enamelon	1 in 1 CARTON	PASTE, DENTIFRICE	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)	INACTIVE INGREDIENT	5216H1HX5F	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
LAUROYL SARCOSINE	INACTIVE INGREDIENT	LIJ19P3L6F	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48783-520	ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]	6	Current NDC, Legacy NDC, 2 package rows	20241027_1626375a-f78b-4192-b7f3-ca932acab7fb.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 15 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Family Dollar Stores, Inc	32ebc633-5338-4d5a-b075-f10b24761248	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	H E B	51ddc81b-1c90-4998-b538-6761ac113437	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	9a0b6301-2443-41f7-adeb-87578a65c26d	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	344c9d00-ad82-46a9-83e9-68197e1a68bb	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M021
TheraBreath Complete Oral Rinse	ANTICAVITY ORAL RINSE	Church & Dwight Co., Inc.	27c33ae1-52c7-baad-e063-6394a90a0611	2026-02-23	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Meijer, Inc.	001777fb-196c-499a-94c8-6cdcef0958e9	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	c628d02f-c834-42b3-b38d-6b9cdcdd0961	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Meijer, Inc.	b17f7a5d-272e-446d-803b-46a6d8e5f18f	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Meijer, Inc.	d85ce60c-ebff-461f-827a-10fddb9c2bf3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	580c4622-6f9c-48ea-b01e-6ffba7273f24	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Coffee and Tea Stain Remover Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	f044e213-2403-4f42-a41d-72d58fefcfcb	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Mouthwash Protect Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4691584f-8c0c-4589-8b40-89b1779a438d	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Professional Choice Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	ed8d7506-0385-4422-be77-bcc2db79882f	2026-02-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Meijer, Inc.	c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Meijer, Inc.	af34f83f-1328-4897-9d04-72ca5a4101bf	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	acff939e-e98c-4d89-a0c4-0254dc74e672	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Meijer, Inc.	0bb9fb5f-1893-4187-b60b-05319a8fac6a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Listerine Total Care Intense Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	4b0404af-309f-7c31-e063-6294a90a5aa1	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Target Corporation	abfc1973-60ab-44e5-8147-33739d8bd7a3	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Target Corporation	3e4119b2-9506-4305-8cff-163f700265d0	2026-02-18	Warnings, Adverse reactions	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
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	PSN	1626375a-f78b-4192-b7f3-ca932acab7fb	7
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	1626375a-f78b-4192-b7f3-ca932acab7fb	7
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	1626375a-f78b-4192-b7f3-ca932acab7fb	7
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	1626375a-f78b-4192-b7f3-ca932acab7fb	7
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	1626375a-f78b-4192-b7f3-ca932acab7fb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48783-520-08	48783052008	1 TUBE in 1 CARTON (48783-520-08) > 21.2 g in 1 TUBE	1 tube	2014-01-01	0000-00-00	No	No	Current
48783-520-43	48783052043	1 TUBE in 1 CARTON (48783-520-43) / 122 g in 1 TUBE	1 tube	2014-01-01	0000-00-00	No	No	Current