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PlainMeds

Over-the-counter medicine

Sodium monofluorophosphate First approved as Extra-Strength Aim

Sodium monofluorophosphate (Extra-Strength Aim) is an over-the-counter medicine with an FDA approval on record since 1986. No generic is listed in FDA's NDC Directory.

  • No generic listed
  • Over the counter

Check it at the source: the sodium monofluorophosphate FDA label on DailyMed (effective February 5, 2026); the NDA 19518 record on Drugs@FDA; every sodium monofluorophosphate label on DailyMed.

Highlights of the record

FDA label of February 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

Helps protect against cavities

Forms and strengths

  • 0.1 g/100g
  • 0.13 g/100g
  • 0.14 g/100g
  • 0.15 g/100g
  • 0.72 g/100g
  • 0.74 g/100g
  • 0.758 g/100g
  • 0.76 g/100g
  • 0.76 g/1001
  • 0.76 g/g
  • 0.83 g/100g
  • 0.884 g/100g

Paste (dentifrice); kit; paste; gel (dentifrice); tablet.

On the market

Earliest approval on file
August 6, 1986 Extra-Strength Aim, Chesebrough Ponds; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
66 of which 0 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
0 since 2018 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
FAERS reports
531 through July 30, 2026

What is sodium monofluorophosphate used for?

From the label: indications and usage

Helps protect against cavities

Source: FDA drug label (HAPEE EXPLOSIVE MENTHOL RED 150), LAMOIYAN CORPORATION, effective February 5, 2026 (SPL set 14c14694-6149-40a8-aff2-660d39f7e0c1), via openFDA; the full label on DailyMed

Is there a generic for sodium monofluorophosphate (Extra-Strength Aim)?

No generic sodium monofluorophosphate is approved (Drugs@FDA, October 8, 2026).

  • 1986 earliest approval on file
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has sodium monofluorophosphate been recalled?

The FDA's Enforcement Report lists 1 recall naming sodium monofluorophosphate since 2018: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sodium monofluorophosphate and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
September 17, 2018Class IIMedline Industries Inc not a listed makerMicrobial Contamination of Non-Sterile Product

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for sodium monofluorophosphate?

The FDA Adverse Event Reporting System holds 531 reports that list sodium monofluorophosphate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 57 are coded as a death and 147 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Fatigue48
  • Nausea40
  • Diarrhoea36
  • Dyspnoea35
  • Vomiting30
  • Headache28
  • Malaise26
  • Constipation25

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Sodium monofluorophosphate side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other