FDA.reportPublic FDA data

AP-24 Fluoride

Product NDC
62839-1151
11-digit product format
628391151
Labeler code
62839
Product ID
62839-1151_0b506952-b76a-4687-b597-2ba48bed56ff
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
NSE Products, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-05-08
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
9 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62839-1151DDiscontinued by firm2026-10-15
excluded packagepackage62839-115162839-1151-1DDiscontinued 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
62839-1151AP-24 FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [NSE PRODUCTS, INC]2Legacy NDC20250112_62d424ae-0d2d-44d5-a1d6-ceb534acc130.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62839-1151-162839115101170 g in 1 TUBE (62839-1151-1) 170 g2017-05-080000-00-00NoNoCurrent