Acetaminophen AND Codeine Phosphate · Regulatory label update

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental REMS (Risk Evaluation and Mitigation Strategy) submission for acetaminophen–codeine phosphate tablets on 18 June 2026. This action specifies risk management requirements for three formulations (15 mg, 30 mg, and 60 mg codeine with 300 mg acetaminophen). This record documents regulatory oversight and does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for acetaminophen and codeine phosphate tablets Three formulations approved: 300 mg acetaminophen + 15 mg, 30 mg, or 60 mg codeine phosphate Sponsor: Aurolife Pharma LLC; approval date 18 June 2026

Safety

This is a regulatory approval record, not a clinical trial; no clinical efficacy or safety trial results are reported. Information about why this supplement was necessary (e.g., new safety signal, labelling change) is not disclosed in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval action for a risk evaluation and mitigation strategy (REMS) affecting acetaminophen–codeine combination products; does not report clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval statusSupplemental REMS approval

Approval date2026-06-18

Acetaminophen dose (all formulations)300 mg

Codeine phosphate doses15 mg, 30 mg, 60 mg

Caveats

This is a regulatory approval record, not a clinical trial; no clinical efficacy or safety trial results are reported.
The record does not specify the rationale for the REMS requirement or the risk management measures mandated.
No comparative data, outcome measures, or population characteristics are provided.
Information about why this supplement was necessary (e.g., new safety signal, labelling change) is not disclosed in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action record, not a clinical study.

Directness

insufficient

Regulatory approval does not directly measure clinical efficacy or safety outcomes.

Consistency

insufficient

No comparative or confirmatory data reported in this record.

Risk of bias

insufficient

Risk of bias assessment does not apply to regulatory approval actions.

Sample adequacy

insufficient

No clinical trial sample or population reported in this record.

Source abstract

Drugs@FDA record for application ANDA202800. This is a regulatory action record, not a clinical study. Brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE. Active ingredient: ACETAMINOPHEN AND CODEINE PHOSPHATE. Sponsor: AUROLIFE PHARMA LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 60MG; ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 15MG; ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 30MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Acetaminophen AND Codeine PhosphateAurolife Pharma