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Prescription medicine · generic available

Fenoprofen calcium

Brand names: Fenopron Tm

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
6Companies
2022First FDA approval on file

Quick answers

What is Fenoprofen calcium used for?
The FDA-approved label (Fenopron Tm, Galt Pharmaceuticals, LLC, February 16, 2026) says: “FENOPRON TM is indicated for: Relief of mild to moderate pain in adults Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis Fenoprofen calcium is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. Relief of the signs and symptoms of rheumatoid arthritis. Relief of the signs and symptoms of osteoarthritis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Fenoprofen calcium have a boxed warning?
Yes. The FDA label for Fenopron Tm has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Fenoprofen calcium?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Fenoprofen calcium been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Fenoprofen calcium?
6 companies list prescription products of Fenoprofen calcium in the FDA NDC Directory, including Misemer Pharmaceuticals, Inc., Rising Pharma Holdings, Inc. and Atland Pharmaceuticals, LLC.

What Fenoprofen calcium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

FENOPRON TM is indicated for: Relief of mild to moderate pain in adults Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis Fenoprofen calcium is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. Relief of the signs and symptoms of rheumatoid arthritis. Relief of the signs and symptoms of osteoarthritis.

— FDA label: Fenopron Tm, Galt Pharmaceuticals, LLC, effective February 16, 2026. Read the full label on DailyMed →

The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Rheumatoid arthritis

Related medical specialties

Rheumatology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Read it on the full label →

7 of 7 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule
RouteOral
Prescription products11 in the FDA NDC Directory
Brand namesFenopron Tm

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (2)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)197694, 197695, 858116, 2699827
SPL set ID of the quoted label2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0
FDA labels (SPL)7
FDA applications2 ANDA
Active ingredients (FDA)FENOPROFEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Fenopron Tm, Galt Pharmaceuticals, LLC, effective February 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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