Quick answers
- What is Oxycodone and aspirin used for?
- The FDA-approved label (Oxycodone and Aspirin, Epic Pharma, LLC, December 17, 2025) says: “Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS ), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxycodone and aspirin have a boxed warning?
- Yes. The FDA label for Oxycodone and Aspirin has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ASPIRIN TABLETS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxycodone and aspirin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxycodone and aspirin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oxycodone and aspirin?
- 1 company lists prescription products of Oxycodone and aspirin in the FDA NDC Directory, including Epic Pharma, LLC.
What Oxycodone and aspirin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS ), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g. …
— FDA label: Oxycodone and Aspirin, Epic Pharma, LLC, effective December 17, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ASPIRIN TABLETS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
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.
- Epic Pharma, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA040910Epic Pharma LLC · July 16, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 848768 |
|---|---|
| SPL set ID of the quoted label | 3292a7c6-5ba3-4563-bc62-e43040634123 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | ASPIRIN / OXYCODONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxycodone and Aspirin, Epic Pharma, LLC, effective December 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →