NEUTRAMAXX 5000

Product NDC
63783-502
Requested package NDC
63783-502-04
11-digit product format
637830502
Labeler code
63783
Product ID
63783-502_6e5e9034-b8fe-4c31-a51d-f1effafd8b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Massco Dental A Division of Dunagin Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-01
Marketing end
2023-12-31
Substance
SODIUM FLUORIDE
Active strength
1 g/112g
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63783-50263783-502-04DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63783-502NEUTRAMAXX 5000 TRI-CALCIUM PHOSPHATE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]5Legacy NDC20231218_b1d6f61d-ab42-4e36-84c7-c665b3a43b79.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63783-502-0463783050204112 g in 1 TUBE (63783-502-04) 112 g2011-08-012023-12-31NoNoCurrent