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Over-the-counter medicine

Isopropyl alcohol First approved as Zuragard

Isopropyl alcohol (Zuragard) is an over-the-counter medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $0.091 per mL (Swim ear drops) in the October 7, 2026 NADAC survey.

  • No generic listed
  • Over the counter

Check it at the source: the isopropyl alcohol FDA label on DailyMed (effective August 26, 2026); the NDA 210872 record on Drugs@FDA; every isopropyl alcohol label on DailyMed.

Highlights of the record

FDA label of August 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Section Use Section

Forms and strengths

  • 0.7 ml
  • 700 ml
  • 0.7 ml/ml
  • 0.7 g/g
  • 0.7 ml/g
  • 0.75 ml/ml
  • 0.91 ml/ml
  • 0.91 mg/ml
  • 50 ml/100ml
  • 70 ml/100ml
  • 70 g/100g
  • 70 ml/100g

Liquid; swab; cloth; solution; spray.

On the market

Earliest approval on file
April 26, 2019 Zuragard, Zurex Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
267 of which 0 under generic applications, 0 under brand applications, repackagers included
Last listed patent
April 24, 2036 Zuragard solution; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$0.091 per mL Swim ear drops
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
0 since 2021 0 Class I among all firms' recalls; 14 more by firms not listed as its makers
FAERS reports
41,892 through July 30, 2026

What is isopropyl alcohol used for?

From the label: indications and usage

Section Use Section

Source: FDA drug label (Stone Hand Sanitizer), handetizer, LLC., effective August 26, 2026 (SPL set 59f821e0-b129-5c39-e063-6294a90a47a0), via openFDA; the full label on DailyMed

Is there a generic for isopropyl alcohol (Zuragard)?

No generic isopropyl alcohol is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Zuragard solution, the last expiring on April 24, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2019 earliest approval on file
  • 2036 last listed patent
  • red ticks recalls

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

What do pharmacies pay for isopropyl alcohol (Zuragard)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.091 per mL (Swim ear drops), down 2% from $0.0928 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Alcohol 70% prep pads (generic)
$0.0139
$0.0133
October 2025October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Alcohol 70% prep padsGeneric$0.0136 per unitn/a+4%
Ear drops for swimmersGeneric$0.0835 per mLn/a+30%
Ft isopropyl alcohol 91%Generic$0.0537 per mLn/a-4%
Gnp isopropyl alcohol 91%Generic$0.0537 per mLn/a-4%
Hm isopropyl alcohol 91%Generic$0.0537 per mLn/a-4%
Qc alcohol 70% prep padsGeneric$0.0136 per unitn/a+4%
Swim ear dropsGeneric$0.091 per mLn/a-2%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has isopropyl alcohol been recalled?

The FDA's Enforcement Report lists 14 recalls naming isopropyl alcohol since 2021: 0 Class I (the most serious), 12 Class II, 2 Class III; 11 still ongoing. 14 of them are by firms that FDA's NDC Directory does not list as a maker of isopropyl alcohol and that hold 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
January 20, 2026Class IIACME UNITED CORPORATION not a listed makerCGMP Deviations
August 25, 2025Class IIIConsumer Product Partners, LLC not a listed makerCross Contamination with Other Products.
July 7, 2025Class IIMEDLINE INDUSTRIES, LP - Northfield not a listed makerSubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
February 17, 2025Class IIMEDLINE INDUSTRIES, LP - Northfield not a listed makerSubpotent Drug
June 29, 2022Class IIMckesson Medical-Surgical Inc. Corporate Office not a listed makerCGMP Deviations: products were stored outside the drug label specifications.
June 15, 2022Class IIVi-Jon, LLC not a listed makerDefective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and …
September 9, 2021Class IIVi-Jon, Inc. not a listed makerLabeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on …

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

What do FAERS reports show for isopropyl alcohol?

The FDA Adverse Event Reporting System holds 41,892 reports that list isopropyl alcohol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24,766 are coded as a death and 13,510 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

  • Completed Suicide (an outcome recorded in the report)8,268
  • Toxicity To Various Agents7,798
  • Drug Abuse6,963
  • Death (an outcome recorded in the report)2,960
  • Overdose (a use or a product term, not a reaction)2,478
  • Cardio-Respiratory Arrest2,174
  • Vomiting2,042
  • Intentional Overdose (a use or a product term, not a reaction)1,969

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

What next?

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