FreshMax Fluoride Regular Flavor

Product NDC
52862-500
Requested package NDC
52862-500-00
11-digit product format
528620500
Labeler code
52862
Product ID
52862-500_eae2cf5d-e149-aa8b-e053-2a95a90aca96
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
International Wholesale Inc
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-02-27
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
76 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52862-50052862-500-00DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52862-50052862-500-00DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
52862-500FRESHMAX FLUORIDE REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE [INTERNATIONAL WHOLESALE INC]6Legacy NDC20250108_499bb6c3-a6d7-2a5d-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-500-00528620500001 TUBE in 1 BOX (52862-500-00) > 181 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent