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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	ef63e193-5804-4b35-bae7-cad29cf4e8bc	2026-01-12	Warnings	Exact identifier application number: M021
Prime Tooth Care Blueberry	SODIUM FLUORIDE	Prime Tooth Care LLC	86642110-4572-4b8b-88f1-8d25fe05701e	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Juicy Peach	SODIUM FLUORIDE	Prime Tooth Care LLC	142f1610-3494-459f-a956-760e82169b87	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Coconut Whip	SODIUM FLUORIDE	Prime Tooth Care LLC	55e95657-9415-4d9c-ac9b-d021aa14e64d	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Hami Melon	SODIUM FLUORIDE	Prime Tooth Care LLC	0028f88d-a9fe-4cfa-a6c6-168f9689b5f6	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Mango Smoothie	SODIUM FLUORIDE	Prime Tooth Care LLC	2f2cf851-2edc-4aaf-9083-c37bc58547de	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Strawberries	SODIUM FLUORIDE	Prime Tooth Care LLC	7b4328bd-5d2d-40ca-8322-5e818e1babf9	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	Prime Tooth Care LLC	b7c731a1-80e7-4571-a568-db0290a720c1	2026-01-09	Warnings	Exact identifier application number: M021
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	Prime Tooth Care LLC	93259174-447d-4f7a-8e55-990eb8da5151	2026-01-09	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Enamel Protect	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f32d5708-8cb1-6499-e053-2995a90ac632	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Complete Care Anticavity Fluoride	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3a644c0-da04-276d-e053-2a95a90abf27	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Active Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4487d78-1da8-3f33-e053-2a95a90a6d92	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Sensitive Care	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f435c1fe-7fbb-1b25-e053-2995a90aca11	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	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