FDA — authorised 3 December 1957
- Application: NDA011265
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 DEXTROMETHORPHAN HYDROBROMIDE in United States
FDA authorised DEXTROMETHORPHAN HYDROBROMIDE on 3 December 1957 · 4,279 US adverse-event reports
Marketing authorisations
FDA — authorised 2 March 1987
- Application: ANDA088913
- Marketing authorisation holder: HALSEY
- Local brand name: PHERAZINE DM
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 July 1996
- Application: ANDA040027
- Marketing authorisation holder: HIKMA
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 April 2004
- Application: NDA021620
- Marketing authorisation holder: RB HLTH
- Local brand name: MUCINEX DM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 February 2006
- Application: ANDA040649
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: PROMETHAZINE DM
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 8 February 2011
- Application: ANDA090575
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 June 2012
- Application: ANDA091687
- Marketing authorisation holder: COSETTE
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 15 July 2014
- Application: ANDA205292
- Marketing authorisation holder: PADAGIS US
- Status: approved
FDA — authorised 20 September 2016
- Application: ANDA203375
- Marketing authorisation holder: ACELLA
- Status: approved
FDA — authorised 17 March 2017
- Application: ANDA206941
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 March 2018
- Application: ANDA207602
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 November 2018
- Application: ANDA209692
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 December 2018
- Application: ANDA207676
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 17 April 2020
- Application: ANDA213125
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Status: approved
FDA — authorised 1 July 2021
- Application: ANDA214781
- Marketing authorisation holder: SUN PHARM
- Local brand name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 August 2023
- Application: ANDA217340
- Marketing authorisation holder: DR REDDYS
- Local brand name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2025
- Application: NDA217338
- Marketing authorisation holder: RB HLTH
- Local brand name: MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA granted marketing authorisation to RB HLTH for DEXTROMETHORPHAN HYDROBROMIDE under the brand name MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM. This approval is for extended-release oral tablets. The approval date was 22 December 2025, and the application number is NDA217338.
FDA — authorised 12 March 2026
- Application: ANDA218264
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
The FDA granted marketing authorisation to HETERO LABS LTD III for DEXTROMETHORPHAN HYDROBROMIDE syrup on 12 March 2026. This approval allows the company to market the product, known as PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, in the United States. The product is indicated for oral use.
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: 20 April 2025 – 20 April 2026
- Total reports: 4,279
Most-reported reactions
- Death — 1,500 reports (35.05%)
- Drug Ineffective — 522 reports (12.2%)
- Drug Abuse — 326 reports (7.62%)
- Toxicity To Various Agents — 318 reports (7.43%)
- Diarrhoea — 315 reports (7.36%)
- Nausea — 284 reports (6.64%)
- Dizziness — 280 reports (6.54%)
- Off Label Use — 252 reports (5.89%)
- Dyspnoea — 241 reports (5.63%)
- Pyrexia — 241 reports (5.63%)
DEXTROMETHORPHAN HYDROBROMIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DEXTROMETHORPHAN HYDROBROMIDE approved in United States?
Yes. FDA authorised it on 3 December 1957; FDA authorised it on 2 March 1987; FDA authorised it on 31 July 1996.
Who is the marketing authorisation holder for DEXTROMETHORPHAN HYDROBROMIDE in United States?
ANI PHARMS holds the US marketing authorisation.