Prescription and over-the-counter medicine

Capsaicin Brand names: Qutenza

Capsaicin (Qutenza) is a prescription and over-the-counter medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $0.207 per gram (Capsaicin 0.1% cream) in the October 7, 2026 NADAC survey.

No generic listed

Check it at the source: the capsaicin FDA label on DailyMed (effective August 21, 2026); the NDA 22395 record on Drugs@FDA; every capsaicin label on DailyMed.

Highlights of the record

FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Temporarily relieves minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
sprains

Forms and strengths

Kit.

On the market

Earliest approval on file: November 16, 2009 Qutenza, Averitas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included; 77 more under the over-the-counter monograph, without an application
Last listed patent: March 26, 2030 Qutenza patch; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $0.207 per gram Capsaicin 0.1% cream
Shortage (FDA): No current entry
Recalls by its makers (FDA): 0 since 2023 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
FAERS reports: 3,274 through July 30, 2026

What is capsaicin used for?

From the label: indications and usage
Temporarily relieves minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
sprains

Conditions named in the indications of capsaicin's FDA labels, with every medicine labeled for each:

Pain

From other capsaicin labels
Pain: Uses Temporary relief of minor pain of muscles and joints associated with:

Source: FDA drug label (Capsaicin 0.035 Percent), Preferred Pharmaceuticals Inc., effective August 21, 2026 (SPL set 0fabc025-4208-45f5-b3c2-543ae3a2df41), via openFDA; the full label on DailyMed

What does the patient leaflet for capsaicin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o older age o longer use of NSAIDs o poor health o smoking o advanced liver disease o drinking alcohol o bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed

Source: FDA drug label (Capsaicin), Rugby Laboratories, effective June 13, 2024 (SPL set c1f0ff98-c000-40a9-b770-da5813647dd8), via openFDA; the full label on DailyMed

Is there a generic for capsaicin (Qutenza)?

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

The Orange Book lists 2 patents for Qutenza patch, the last expiring on March 26, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2009 earliest approval on file
2030 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 capsaicin (Qutenza)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.207 per gram (Capsaicin 0.1% cream), up 15% from $0.180 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.

Capsaicin 0.1% cream (generic)

$0.233

$0.168

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Arthritis pain rlf 0.075% cream	Generic	$0.0713 per gram	n/a	-6%
Capsaicin 0.025% cream	Generic	$0.082 per gram	n/a	+27%
Capsaicin 0.025% heat patch	Generic	$1.12 per patch	n/a	+11%
Capsaicin 0.075% cream	Generic	$0.0713 per gram	n/a	-6%
Capsaicin 0.1% cream	Generic	$0.207 per gram	n/a	+15%
Capsimide 0.025% patch	Generic	$1.12 per patch	n/a	+11%
Gnp capsaicin 0.025% patch	Generic	$1.12 per patch	n/a	+11%

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

Has capsaicin been recalled?

The FDA's Enforcement Report lists 1 recall naming capsaicin since 2023: 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 capsaicin 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.

Started	Class	Company	Reason
August 11, 2023	Class II	AVKARE LLC not a listed maker	Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

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

What do FAERS reports show for capsaicin?

The FDA Adverse Event Reporting System holds 3,274 reports that list capsaicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 158 are coded as a death and 626 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

Application Site Pain (named in the label)548
Pain (a use or a product term, not a reaction)425
Drug Ineffective (a use or a product term, not a reaction)371
Burning Sensation (named in the label)329
Pain In Extremity215
Fatigue164
Application Site Erythema (named in the label)149
Off Label Use (a use or a product term, not a reaction)147

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

What next?

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