Regulatory PathRegulatory requirements compared

Active substances

Codeine + Paracetamol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
REVACOD500, 10 mgTablet · Oral use20 BlisterSAR 4.10NCE · PrescriptionAPMWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGtablet · oralSUN PHARM INDS LTDPrescription23 Jan 1980
ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLsolution · oralGENUS LIFESCIENCESPrescription21 Aug 1981
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGtablet · oralSTRIDES PHARMA INTLPrescription30 Sep 1988
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGtablet · oralSTRIDES PHARMA INTLPrescription30 Sep 1988
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGtablet · oralSTRIDES PHARMA INTLPrescription30 Sep 1988
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MG; 300MG;30MG; 300MG;60MGtablet · oralSPECGX LLCPrescription31 May 2001
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGtablet · oralAMNEAL PHARMS NYPrescription29 May 2008
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MG; 300MG;30MG; 300MG;60MGtablet · oralAUROLIFE PHARMA LLCPrescription15 Apr 2013
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MG; 300MG;30MG; 300MG;60MGtablet · oralADAPTISPrescription27 Jun 2019
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MG; 300MG;30MG; 300MG;60MGtablet · oralELITE LABS INCPrescription10 Sep 2019
CAPITAL AND CODEINE325MG;30MGtablet · oralCARNRICKDiscontinued31 May 1974
PHENAPHEN W/ CODEINE NO. 3325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralROBINS AHDiscontinued22 Jul 1975
PHENAPHEN W/ CODEINE NO. 4325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralROBINS AHDiscontinued22 Jul 1975
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGtablet · oralROXANEDiscontinued10 May 1976
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGtablet · oralROXANEDiscontinued10 May 1976
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGtablet · oralROXANEDiscontinued10 May 1976
TYLENOL W/ CODEINE325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralORTHO MCNEIL PHARMDiscontinued9 Jul 1976
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGtablet · oralSANDOZDiscontinued10 Feb 1977
TYLENOL W/ CODEINE NO. 1300MG;7.5MGtablet · oralJANSSEN PHARMSDiscontinued17 Aug 1977
TYLENOL W/ CODEINE NO. 2300MG;15MGtablet · oralJANSSEN PHARMSDiscontinued17 Aug 1977
TYLENOL W/ CODEINE NO. 3300MG;30MGtablet · oralJANSSEN PHARMSDiscontinued17 Aug 1977
TYLENOL W/ CODEINE NO. 4300MG;60MGtablet · oralJANSSEN PHARMSDiscontinued17 Aug 1977
ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGtablet · oralKV PHARMDiscontinued23 Aug 1977
ACETAMINOPHEN AND CODEINE PHOSPHATE325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralKV PHARMDiscontinued23 Aug 1977
ACETAMINOPHEN AND CODEINE PHOSPHATE325MG;15MGtablet · oralKV PHARMDiscontinued23 Aug 1977

87 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PMS-ACETAMINOPHEN WITH CODEINE ELIXIR008160278 MG / 5 ML; 160 MG / 5 MLELIXIR · ORALPHARMASCIENCE INC
TEVA-EMTEC-300060888230 MG; 300 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-LENOLTEC NO. 40062146360 MG; 300 MGTABLET · ORALTEVA CANADA LIMITED
TRIATEC-3000789828300 MG; 30 MGTABLET · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACACETAMINOPHEN-COD #2 TABLET$0.26941per EA23 Sep 2026
US NADACACETAMINOPHEN-COD #3 TABLET$0.25557per EA23 Sep 2026
US NADACACETAMINOPHEN-COD #4 TABLET$0.38902per EA23 Sep 2026
US NADACACETAMINOPHEN-CODEINE 120 MG-12 MG/5 ML SOLUTION$0.46877per ML23 Sep 2026
NHS Drug TariffCo-codamol 12.8mg/500mg tablets£5.0424 tablet1 Oct 2026
NHS Drug TariffCo-codamol 15mg/500mg capsules£7.25100 capsule1 Oct 2026
NHS Drug TariffCo-codamol 15mg/500mg effervescent tablets sugar free£12.88100 tablet1 Oct 2026
NHS Drug TariffCo-codamol 15mg/500mg tablets£3.63100 tablet1 Oct 2026
NHS Drug TariffCo-codamol 30mg/500mg capsules£6.20100 capsule1 Oct 2026
NHS Drug TariffCo-codamol 30mg/500mg effervescent tablets£2.5332 tablet1 Oct 2026
NHS Drug TariffCo-codamol 30mg/500mg effervescent tablets£7.91100 tablet1 Oct 2026
NHS Drug TariffCo-codamol 30mg/500mg tablets£2.5730 tablet1 Oct 2026
NHS Drug TariffCo-codamol 30mg/500mg tablets£8.57100 tablet1 Oct 2026
NHS Drug TariffCo-codamol 8mg/500mg capsules£5.7232 capsule1 Oct 2026
NHS Drug TariffCo-codamol 8mg/500mg capsules£17.87100 capsule1 Oct 2026
NHS Drug TariffCo-codamol 8mg/500mg effervescent tablets£3.2432 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.