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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE STRAWBERRY BURST	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	08d7ed04-67a4-437a-82c5-496f9893c6c7	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	27278b02-c4fd-4092-a632-a14e442f5a95	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	59a6b9ac-c28b-4ec3-8231-f35054ce0eaf	2026-08-10	Warnings	Exact identifier application number: M021
Toms Kids Watermelon Wiggle	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	64b60e74-fceb-4de9-a966-73bf8dbd666c	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	7e880d50-8aab-4d57-abc1-e900070f9a11	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	5cb5eb46-705c-4bb7-bef1-e93a598636fd	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	0e043431-9d87-478d-87f5-5aa8b0a932eb	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	19de1e71-ab94-415f-b66d-e5748dea8317	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	d5e1396e-0253-4ec0-a9ff-b61bda70de35	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED COOL MILD MINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	de92408c-d401-47c3-94ee-fb6c08092651	2026-08-10	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
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