Skip to main content

Two medicines, side by side

Diclofenac vs methyl salicylate

Diclofenac and methyl salicylate are both labeled for pain. Only the diclofenac label carries a boxed warning.

Check it at the source: the diclofenac FDA label on DailyMed (effective February 11, 2025); the methyl salicylate FDA label on DailyMed (effective July 10, 2026).

Highlights of the diclofenac record

Diclofenac (Voltaren) · label of February 11, 2025

Used for

From the label: indications

• for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o foot, ankle, knee (lower body areas) • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

On the market

Earliest approval on file
July 28, 1988
Generic labelers
149 labelers
Pharmacy cost
$0.0619 per tablet

Supply and safety

Shortage
A presentation being discontinued
Recalls
6

Highlights of the methyl salicylate record

Methyl salicylate · label of July 10, 2026

Used for

From the label: indications

Uses for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains provides penetrating pain relief provides warming pain relief

On the market

Earliest approval on file
n/a
Generic labelers
none listed
Pharmacy cost
Not in the survey

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Diclofenac label of February 11, 2025, Methyl salicylate label of July 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do diclofenac and methyl salicylate differ on the record?

Only the diclofenac label carries a boxed warning.

Generics: diclofenac since 1995; methyl salicylate none approved (Drugs@FDA).

DiclofenacMethyl salicylate
Labeled forPain, Osteoarthritis, Rheumatoid arthritis, MigrainePain
Pharmacologic classNonsteroidal Anti-inflammatory Drugn/a
How it works (label)n/an/a
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)July 28, 1988n/a
First generic approvedJune 29, 1995none
Generic labelers (NDC)149 labelersnone listed
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0619 per tablet (Diclofenac sod DR 75 mg tablet)n/a
12-month price change-25%n/a
Boxed warningYesNo
Shortage nowA presentation being discontinuedNo current entry
Recalls recorded60
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)158,675228
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What do the labels say about using others of their kind?

Diclofenac label, drug interactions (prescription label)

The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Source: FDA drug labels via openFDA

What next?

Alternatives to diclofenac
every medicine labeled for the same conditions