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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	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