Prescription medicine
Acetaminophen and codeine
Acetaminophen and codeine is a prescription medicine. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.256 per acetaminophen-cod #3 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the acetaminophen and codeine FDA label on DailyMed (effective June 12, 2026); every acetaminophen and codeine label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS.
Addiction, Abuse, and Misuse Because the use of acetaminophen and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions ( see WARNINGS ). Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of acetaminophen and codeine phosphate tablets are essential ( see WARNINGS ). Accidental Ingestion Accidental ingestion of even one dose of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine ( see WARNINGS ). Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageAcetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Forms and strengths
- 120 mg/5ml / 12 mg/5ml
- 300 mg / 30 mg
- 300 mg / 60 mg
- 300 mg / 15 mg
- 300 mg/12.5ml / 30 mg/12.5ml
Tablet; solution.
On the market
- Generic approvals
- 98 first May 31, 1974; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 24 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.256 per tablet Acetaminophen-cod #3 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2014 0 Class I among all firms' recalls; latest March 18, 2020
- FAERS reports
- 14,001 through July 30, 2026
What is acetaminophen and codeine used for?
From the label: indications and usageAcetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 ( see WARNINGS ), reserve opioid analgesics, including acetaminophen and codeine phosphate 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.
Conditions named in the indications of acetaminophen and codeine's FDA labels, with every medicine labeled for each:
From other acetaminophen and codeine labelsPain: INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (ACETAMINOPHEN AND CODEINE PHOSPHATE), SpecGx LLC, effective June 12, 2026 (SPL set eadc80fa-13c3-471a-a22f-6fe7e1ab290f), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and codeine?
The FDA approved the first generic acetaminophen and codeine on May 31, 1974. 98 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and codeine from 24 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and codeine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.256 per Acetaminophen-cod #3 tablet, down 7% from $0.275 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acetaminophen-cod #3 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acetaminophen-cod #2 tablet | Generic | $0.269 per tablet | $8.08 | -9% |
| Acetaminophen-cod #3 tablet | Generic | $0.256 per tablet | $7.67 | -7% |
| Acetaminophen-cod #4 tablet | Generic | $0.389 per tablet | $11.67 | -12% |
| Acetaminophen-codeine 120 mg-12 mg/5 mL solution | Generic | $0.469 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetaminophen and codeine been recalled?
The FDA's Enforcement Report lists 5 recalls naming acetaminophen and codeine since 2014: 0 Class I (the most serious), 4 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 18, 2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| April 24, 2018 | Class II | Prescript Pharmaceuticals, Inc. | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15°C to 30°C (59°F to 86°F) which differs from the original manufacturer … |
| December 22, 2014 | Class III | Qualitest Pharmaceuticals | Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetaminophen and codeine label say about other medicines?
The acetaminophen and codeine label names 31 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of acetaminophen and codeine phosphate tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine … |
| Buprenorphine | drug interactions | If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. |
| Bupropion | drug interactions | The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or … |
| Butorphanol | drug interactions | Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of acetaminophen and codeine phosphate tablets and/or precipitate withdrawal symptoms. |
| Carbamazepine | drug interactions | CYP3A4 Inducers The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels ( see CLINICAL PHARMACOLOGY ), resulting in … |
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) ( see PRECAUTIONS, Information for … |
| Erythromycin | drug interactions | CYP3A4 Inhibitors The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations, with … |
| Fluoxetine | drug interactions | The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or … |
| Gabapentin | drug interactions | … other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Hydrocodone | drug interactions | If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. |
| Ketoconazole | drug interactions | CYP3A4 Inhibitors The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations, with … |
| Linezolid | drug interactions | … metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) ( see PRECAUTIONS, Information for Patients/Caregivers ). |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) ( see PRECAUTIONS, Information for … |
| Methylene blue | drug interactions | … oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) ( see PRECAUTIONS, Information for Patients/Caregivers ). |
Every other medicine the acetaminophen and codeine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mirtazapine | drug interactions | … antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase … |
| Morphine | boxed warning | … the effects on the parent drug, codeine, and the active metabolite, morphine ( see WARNINGS and PRECAUTIONS, Drug Interactions ). |
| Nalbuphine | drug interactions | Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic … |
| Nalmefene | warnings | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings | DOSAGE AND ADMINISTRATION, Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose ). |
| Oxycodone | drug interactions | If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat … |
| Oxymorphone | drug interactions | If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat … |
| Paroxetine | drug interactions | The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity. |
| Phenytoin | drug interactions | CYP3A4 Inducers The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater … |
| Pregabalin | drug interactions | … general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Quinidine | drug interactions | The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can … |
| Rifampin | drug interactions | CYP3A4 Inducers The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater … |
| Ritonavir | drug interactions | … azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations, with subsequently greater metabolism by cytochrome … |
| Tramadol | drug interactions | … the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity. |
| Trazodone | drug interactions | … that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used … |
Source: FDA drug label (ACETAMINOPHEN AND CODEINE PHOSPHATE), SpecGx LLC, effective June 12, 2026 (SPL set eadc80fa-13c3-471a-a22f-6fe7e1ab290f), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and codeine?
The FDA Adverse Event Reporting System holds 14,001 reports that list acetaminophen and codeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,616 are coded as a death and 4,768 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (4,202, against a median of 708 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acetaminophen and codeine?
27 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and codeine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
| Tapentadol | Pain | 4 labelers | $14.48 per tablet 100 mg tablet | No current entry |
| Hydrocodone | Pain | 1 labeler | $7.95 per capsule 15 mg capsule | No current entry |
Every medicine labeled for the same conditions as acetaminophen and codeine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acetaminophen and codeine
- 27 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Acetaminophen and codeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other