Home NDC 48783-520 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.
FDA-Initiated Inactive NDC Indexing# 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 Uploaded 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 33 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# 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