FDA label
What is Percocet used for?
Percocet contains oxycodone and acetaminophen. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Percocet, tablet
Indications and Usage, quoted from the label by SpecGx LLC (ANDA040330). Cross-references to other label sections are left out.
PERCOCET is 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 4dd36cf5-8f73-404a-8b1d-3bd53bd90c25, version 66, effective October 2, 2026. NDC 63481-623, one of 3 listings for this product.
Percocet, tablet
Indications and Usage, quoted from the label by Direct_Rx (ANDA201278). Cross-references to other label sections are left out.
Oxycodone and Acetaminophen Tablets, USP 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, even at recommended doses, reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Source: DailyMed label, set id ee151649-b52a-0a51-e053-2a95a90a6c35, version 2, effective January 22, 2025. NDC 72189-397, one of 1 listing for this product.
Questions
What is Percocet used for?
The FDA label says: “PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is Percocet?
FDA lists oxycodone and acetaminophen in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Percocet
- Is Percocet a controlled substance?Schedule II
- What is Oxycodone and Acetaminophen used for?FDA label uses
- Is Oxycodone and Acetaminophen a controlled substance?Schedule II
- Opioid Agonists listFDA drug class
- NDC 63481-623Percocet NDC record
- NDC 63481-628Percocet NDC record
- NDC 63481-629Percocet NDC record
- Schedule II drugs listDEA schedule