Regulatory PathRegulatory requirements compared

Active substance

Dicloxacillin

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DICLOXACILLIN SODIUMEQ 250MG BASE; EQ 500MG BASEcapsule · oralCHARTWELL RXPrescription3 Jun 1982
DICLOXACILLIN SODIUMEQ 250MG BASE; EQ 500MG BASEcapsule · oralAUROBINDO PHARMAPrescription23 Sep 2022
PATHOCILEQ 62.5MG BASE/5MLfor suspension · oralWYETH AYERSTDiscontinued22 Apr 1968
PATHOCILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralWYETH AYERSTDiscontinued9 May 1968
DICLOXACILLIN SODIUMEQ 250MG BASE; EQ 125MG BASE; EQ 500MG BASEcapsule · oralCHARTWELL RXDiscontinued1 Apr 1971
DICLOXACILLIN SODIUMEQ 62.5MG BASE/5MLfor suspension · oralAPOTHECONDiscontinued1 Apr 1971
DYCILLEQ 250MG BASE; EQ 500MG BASEcapsule · oralGLAXOSMITHKLINEDiscontinued31 Dec 1979
DYCILLEQ 250MG BASE; EQ 500MG BASEcapsule · oralGLAXOSMITHKLINEDiscontinued
DYNAPENEQ 62.5MG BASE/5MLfor suspension · oralAPOTHECONDiscontinued

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDICLOXACILLIN 250 MG CAPSULE$0.59036per EA23 Sep 2026
US NADACDICLOXACILLIN 500 MG CAPSULE$0.92742per EA23 Sep 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.1. Access group antibiotics · core
    First choice: Therapeutic equivalent to cloxacillin for Bacterial infection of joint; First choice: Therapeutic equivalent to cloxacillin for Osteomyelitis or osteitis; First choice: Therapeutic equivalent to cloxacillin for Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Therapeutic equivalent to cloxacillin for Sepsis without septic shock

Safety signals and safety-related labeling changes

All safety entries for dicloxacillin →

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.