Home NDC 63783-504 NEUTRA MAXX 5000
Product NDC 63783-504
11-digit product format 637830504
Labeler code 63783
Product ID 63783-504_cb8064d7-2d0f-4860-b794-d90a121761ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL
Route ORAL
Labeler Massco Dental A Division of Dunagin Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1989-01-01
Substance SODIUM FLUORIDE
Active strength 1.428 g/120g
NDC exclude flag No
Listing certified through 2026-12-31
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 NEUTRA MAXX 5000
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.428 g/120g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 392038 Internal RxNorm lookup 1191716 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63783-504-06 NEUTRA MAXX 5000 120 g in 1 BOTTLE, DISPENSING GEL 120 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63783-504 NEUTRA MAXX 5000 (SODIUM FLUORIDE) GEL [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 1 package rows 20231218_fcbe6baa-2827-49df-9316-42cc86595203.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 1 of 1 · 1 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 63783-504-06 63783050406 120 g in 1 BOTTLE, DISPENSING (63783-504-06) 120 g 1989-01-01 0000-00-00 No No Current