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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Frida Fluoride Sweet Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b5a39-5d79-72cd-e063-6394a90a475c	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Bubble Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b9af3-e4b3-b5e0-e063-6394a90a1068	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry Toothbrush Set	SODIUM FLUORIDE	Fridababy, LLC	4f8ba14f-60ea-c2a8-e063-6394a90a7702	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry	SODIUM FLUORIDE	Fridababy, LLC	4f814a62-8f91-8ea6-e063-6294a90a69eb	2026-05-06	Warnings	Exact identifier application number: M021
Gum Health Detoxify	STANNOUS FLUORIDE	Meijer, Inc	41d70733-a223-40fb-e063-6294a90a1397	2026-05-06	Warnings	Exact identifier application number: M021
Colgate Kids Unicorn Alcohol Free	SODIUM FLUORIDE	Colgate-Palmolive Company	133acaff-7205-80d7-e91d-3eb37087cae4	2026-05-05	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	fdefffbd-9c05-fa30-e053-6394a90a34bc	2026-05-05	Warnings	Exact identifier application number: M021
Frida Fluoride Watermelon	SODIUM FLUORIDE	Fridababy, LLC	4f8b49dc-e9e4-c341-e063-6294a90adb5a	2026-05-05	Warnings	Exact identifier application number: M021
White Glo Extreme White Whitening	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4a2e0a8d-420e-4c07-aa43-386d05dab472	2026-04-30	Warnings	Exact identifier application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TP	STANNOUS FLUORIDE	Walmart Inc.	1e6561fb-4e3b-40ba-e063-6294a90a2690	2026-04-29	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	852889b4-59ba-4592-b4fc-c0127a1ad075	2026-04-28	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Scope	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	0206710a-707f-4aa9-96b9-86240c1275dc	2026-04-28	Warnings	Exact identifier application number: M021
Alcohol Free Refreshing Mint	SODIUM FLUORIDE	H E B	cedf7c08-7412-4733-9b67-225b331cec8c	2026-04-27	Warnings, Adverse reactions	Exact identifier application number: M021
anzoon ANTIBACTERIAL MOUTH WASH	CETYLPYRIDINIUM CHLORIDE	Shandong AZC Biotechnology Co.,Ltd.	507c6896-2806-790c-e063-6394a90ac5ce	2026-04-27	Warnings	Exact identifier application number: M021
DELTA COMFORT PLUS AMENITY	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	26434794-ae02-0f58-e063-6294a90ad85e	2026-04-24	Warnings	Exact identifier application number: M021
A and H Plus Therabreath Breath Freshners	SODIUM FLUORIDE	Church & Dwight Co., Inc.	18d6073e-b1ee-47d2-9758-2cf04f3cf3ca	2026-04-23	Warnings	Exact identifier application number: M021
Fluoride	SODIUM FLUORIDE	McKesson	5025e58e-e59c-07b6-e063-6394a90ac1e8	2026-04-23	Warnings	Exact identifier application number: M021
PRO-SYS	SENSITIVITY - MINT (OTC)	Benco Dental	4e46847e-8c1d-c988-e063-6394a90a8e50	2026-04-22	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	87327a36-a314-4daa-83b6-b4bd3e26bba2	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	8df324a7-9204-40f3-8ddb-1656286d7d4e	2026-04-22	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