SalivaMAX SalivaMAX 30ct – 04 NDCRecalls & reported problems

Forward Science Technologies LLC · SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis. · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00370275629047), received between Jan 22, 2021 and Jan 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequate Instructions for Non-Healthcare Professional” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Inadequate Instructions for Non-Healthcare Professional1
Product Quality Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 22, 2021Product Quality Problem; Inadequate Instructions for Non-Healthcare Professional
THIS PRODUCT CONSISTS OF SMALL PACKETS OF A FREE FLOWING POWDER. I NOTICED SEVERAL PACKETS THAT WERE SWOLLEN AND THE POWDER HAD CRYSTALIZED WITHIN THE PACKET. THIS IS MEANT TO BE REHYDRATED AND USED AS A MOUTH RINSE. I DID NOT USE ANY OF THE CRYSTALIZED PRODUCT AND CALLED THE COMPANY TO REPORT IT. THEY TOLD ME IT WAS PROBABLY JUST WATER AND/OR AIR THAT GOT IN THE PRODUCT PACKET AND IT WOULD BE FINE TO USE BUT I DO NOT FEEL SAFE USING IT. THIS DIDN'T SEEM TO BE A SATISFACTORY EXPLANATION. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11222640 ↗

Device details

UDI-DI	`00370275629047`
Brand	SalivaMAX
Model	SalivaMAX 30ct – 04 NDC
Company	Forward Science Technologies LLC
Product code	LFD · Saliva, Artificial
Class	Class U
FDA submission	K152406
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 22, 2024

Device type (GMDN): Artificial saliva

An electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. After application, this device cannot be reused.

Other Saliva, Artificial devices

Caphosol® Artifical Saliva 64 x 15 mL sachets aqueous solution
Eusa Pharma (Uk) Limited · Saliva, Artificial
1 recall0 reports
Biotene Mouth Spray
Haleon US Holdings LLC · Saliva, Artificial
1 recall0 reports

All Saliva, Artificial devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page