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 21 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HISMILE SODIUM FLUORIDE HISMILE PTY LTD 1de591d9-9cab-e63d-e063-6394a90ac8eb 2026-01-15 Warnings Exact identifier application number: M021 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 20e1603e-bcd1-6a5e-e063-6294a90ad1db 2026-01-15 Warnings Exact identifier application number: M021 Hismile CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE HISMILE PTY LTD 1e725b7e-accc-f51c-e063-6394a90a455c 2026-01-15 Warnings Exact identifier application number: M021 Enamelon Preventive Treatment STANNOUS FLUORIDE Premier Dental Products Company 04c3f178-7905-404d-9ac2-67c453287ddf 2026-01-13 Warnings Exact identifier application number: M021 Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ndc (product): 48783-520 ARU CAVITY PROTECTION SODIUM FLUORIDE Ashtel Studios, Inc. 97bd2934-4bff-4fdb-9199-fcdc0f77fada 2026-01-13 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Cinnamon SODIUM FLUORIDE Chattem, Inc. f2952ca5-c1c3-42fc-82a4-08662286be44 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Wild Watermelon SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) Chattem, Inc. bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Pineapple Punch SODIUM FLUORIDE Chattem, Inc. 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b 2026-01-12 Warnings Exact identifier application number: M021 Botao Kids Strawberry Flavored with Fluoride BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE Peer Pharm Ltd. 48b8d884-5e15-4145-8521-ae9ee482e392 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 Warnings Exact identifier application number: M021
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