FDA — authorised 21 January 1952
- Application: NDA008306
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PHENERGAN W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 Paracetamol + Codeine in United States
FDA authorised Paracetamol + Codeine on 21 January 1952 · 534 US adverse-event reports
Marketing authorisations
FDA — authorised 5 October 1960
- Application: NDA012366
- Marketing authorisation holder: MEDA PHARMS
- Local brand name: SOMA COMPOUND W/ CODEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1976
- Application: ANDA085056
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYLENOL W/ CODEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1978
- Application: ANDA085640
- Marketing authorisation holder: SCHERER LABS
- Local brand name: CODEINE, ASPIRIN, APAP FORMULA NO. 2
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 1978
- Application: ANDA085638
- Marketing authorisation holder: SCHERER LABS
- Local brand name: CODEINE, ASPIRIN, APAP FORMULA NO. 4
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 1978
- Application: ANDA085639
- Marketing authorisation holder: SCHERER LABS
- Local brand name: CODEINE, ASPIRIN, APAP FORMULA NO. 3
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 October 1984
- Application: ANDA088764
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROMETH VC W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 4 January 1985
- Application: ANDA088896
- Marketing authorisation holder: WOCKHARDT
- Local brand name: PROMETHAZINE VC W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 July 1986
- Application: ANDA089018
- Marketing authorisation holder: CENCI
- Local brand name: TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 2 March 1987
- Application: ANDA088870
- Marketing authorisation holder: HALSEY
- Local brand name: PHERAZINE VC W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 December 1988
- Application: ANDA088739
- Marketing authorisation holder: HALSEY
- Local brand name: PHERAZINE W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 October 1990
- Application: NDA019429
- Marketing authorisation holder: ALLERGAN
- Local brand name: FIORINAL W/CODEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 1992
- Application: NDA020232
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: FIORICET W/ CODEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085057
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYLENOL W/ CODEINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: NDA012575
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ACTIFED W/ CODEINE
- Indication: SYRUP — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 534
Most-reported reactions
- Drug Ineffective — 68 reports (12.73%)
- Dyspnoea — 59 reports (11.05%)
- Pain — 58 reports (10.86%)
- Fatigue — 56 reports (10.49%)
- Arthralgia — 54 reports (10.11%)
- Confusional State — 53 reports (9.93%)
- Vomiting — 52 reports (9.74%)
- Pyrexia — 47 reports (8.8%)
- Overdose — 45 reports (8.43%)
- Diarrhoea — 42 reports (7.87%)
Other Pain Management approved in United States
Frequently asked questions
Is Paracetamol + Codeine approved in United States?
Yes. FDA authorised it on 21 January 1952; FDA authorised it on 5 October 1960; FDA authorised it on 9 July 1976.
Who is the marketing authorisation holder for Paracetamol + Codeine in United States?
ANI PHARMS holds the US marketing authorisation.