FDA label
What is Nalocet used for?
Nalocet 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: “Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Nalocet, tablet
Indications and Usage, quoted from the label by Forte Bio-Pharma LLC (ANDA040608). Cross-references to other label sections are left out.
Oxycodone and acetaminophen 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy, reserve opioid analgesics, including oxycodone and acetaminophen tablets, 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 f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be, version 10, effective August 6, 2026. NDC 72245-193, one of 1 listing for this product.
Questions
What is Nalocet used for?
The FDA label says: “Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is Nalocet?
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.