Quick answers
- What is Acetaminophen and codeine phosphate used for?
- The FDA-approved label (Acetaminophen and Codeine Phosphate, Remedyrepack Inc., August 27, 2026) says: “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. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Acetaminophen and codeine phosphate have a boxed warning?
- Yes. The FDA label for Acetaminophen and Codeine Phosphate has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Acetaminophen and codeine phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Acetaminophen and codeine phosphate been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 18, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Acetaminophen and codeine phosphate?
- 23 companies list prescription products of Acetaminophen and codeine phosphate in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and Proficient Rx LP.
What Acetaminophen and codeine phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. Limitations of Use …
— FDA label: Acetaminophen and Codeine Phosphate, Remedyrepack Inc., effective August 27, 2026. Read the full label on DailyMed →
The FDA has 58 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.
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 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS
. Read it on the full label →
55 of 58 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Solution |
|---|---|
| Route | Oral |
| Prescription products | 74 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 120 mg/5 mL · codeine phosphate 12 mg/5 mL solution | Generic | $0.4699 per mL |
| acetaminophen 300 mg · codeine phosphate 15 mg tablet | Generic | $0.2661 per tablet |
| acetaminophen 300 mg · codeine phosphate 30 mg tablet | Generic | $0.2469 per tablet |
| acetaminophen 300 mg · codeine phosphate 60 mg tablet | Generic | $0.3903 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Bryant Ranch Prepack13 products
- NuCare Pharmaceuticals, Inc.9 products
- Proficient Rx LP5 products
- Advanced Rx of Tennessee, LLC4 products
- Preferred Pharmaceuticals Inc.4 products
- Remedyrepack Inc.4 products
- Eywa Pharma Inc3 products
- A-S Medication Solutions3 products
- Strides Pharma Science Limited3 products
- SpecGx LLC3 products
- Direct_Rx3 products
- Aurolife Pharma, LLC3 products
- Elite Laboratories, Inc.3 products
- Asclemed USA, Inc.2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Clinical Solutions Wholesale, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Amneal Pharmaceuticals LLC1 product
- Genus Lifesciences Inc.1 product
- Redpharm Drug1 product
- RedPharm Drug, Inc.1 product
- Unit Dose Solutions, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA087508Pai Holdings · August 21, 1981
- ANDA089805Strides Pharma Intl · September 30, 1988
- ANDA089828Strides Pharma Intl · September 30, 1988
- ANDA089990Strides Pharma Intl · September 30, 1988
- ANDA040419Specgx LLC · May 31, 2001
- ANDA040779Amneal Pharms Ny · May 29, 2008
- ANDA202800Aurolife Pharma LLC · April 15, 2013
- ANDA211610Adaptis · June 27, 2019
- ANDA212418Elite Labs Inc · September 10, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 18, 2020 · Class II · Terminated · D-1231-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01 — Aurobindo Pharma USA Inc.
-
March 18, 2020 · Class II · Terminated · D-1230-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99 — Aurobindo Pharma USA Inc.
-
March 18, 2020 · Class II · Terminated · D-1229-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01 — Aurobindo Pharma USA Inc.
-
April 24, 2018 · Class II · Terminated · D-0806-2018
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 declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreSc — Prescript Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 993755, 993770, 993781, 993890 |
|---|---|
| SPL set ID of the quoted label | 40d4a71e-341e-48b3-b925-ba35b7910dff |
| FDA labels (SPL) | 58 |
| FDA applications | 9 ANDA |
| Active ingredients (FDA) | ACETAMINOPHEN / CODEINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Acetaminophen and Codeine Phosphate, Remedyrepack Inc., effective August 27, 2026; 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 →