Home NDC 48783-500 Enamelon Preventive Treatment
Product NDC 48783-500
11-digit product format 487830500
Labeler code 48783
Product ID 48783-500_4847e624-6a03-7e43-e063-6394a90a5045
Type HUMAN OTC DRUG
Nonproprietary name stannous fluoride
Dosage form GEL
Route DENTAL
Labeler Premier Dental Products Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-01-01
Substance STANNOUS FLUORIDE
Active strength .004 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 Preventive Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .004 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 237847 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 48783-500-40 Enamelon Preventive Treatment 113 g in 1 TUBE GEL 113 8 48783-500-40 Enamelon Preventive Treatment 1 in 1 CARTON GEL 1 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48783-500 ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY] 7 Current NDC, Legacy NDC, 2 package rows 20241027_04c3f178-7905-404d-9ac2-67c453287ddf.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 48783-500-40 48783050040 1 TUBE in 1 CARTON (48783-500-40) / 113 g in 1 TUBE 1 tube 2014-01-01 0000-00-00 No No Current