Dextromethorphan Hydrobromide shortage — BE supply status & alternatives

Dextromethorphan Hydrobromide

ATC R05DA09

🇦🇺 AUST R 412614 · Neo Health (OTC) Pty Ltd

In supply · Australia

Pulmorphan

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇧🇪 BE🇮🇳 IN

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Dextromethorphan Hydrobromide
Brand names	Pulmorphan
ATC level 5	R05DA09
ATC level 4	R05DA
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No
Marketing-authorisation holders	Neo Health (OTC) Pty Ltd, iNova Pharmaceuticals Australia Pty Ltd, Xttrium Laboratories, Inc, PAI Holdings, LLC dba PAI Pharma +10 more
Registrations on file	20
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

14 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Wockhardt LTDDivis Laboratories LTDSolara Active Pharma Sciences LTDQidong Dongyue Pharmaceutical CO LTDApitoria Pharma Private LTDMalladi Drugs And Pharmaceuticals LTD+8 more

Manufacturing countries: India, China · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

July 1997

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

ANSM Ruptures · 3mo ago

High

🇮🇳

CDSCO · 3h ago

Medium

🇨🇦

Canada

HC · 3h ago

Medium

🇧🇪

FAMHP · 4h ago

Medium

Recalls official enforcement reports

🇺🇸

MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK

Denison Pharmaceuticals, LLC · Sept 2024

Class IIIdetails ↗

🇺🇸

MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK

Denison Pharmaceuticals, LLC · Sept 2024

Class IIIdetails ↗

🇺🇸

NUEDEXTA

Cardinal Health Inc. · Mar 2021

Class IIdetails ↗

Verified timeline regulator events

🇮🇳 1 May 2026

medium reported

🇮🇳 1 Apr 2026

medium reported

🇧🇪 4 Nov 2024

medium reported

🇺🇸 28 May 2019

high reported

🇨🇦 15 Apr 2016

medium reported

🇨🇦 11 Apr 2014

medium reported

Sources official regulators

🇮🇳

CDSCO

verified 3h ago

verify ↗

🇨🇦

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 4h ago

verify ↗

🇺🇸

ANSM Ruptures

verified 3mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders20 registrations · 14 MA holders

Product	Strength	Form	Market	MA holder	Status
NEODRYL DRY COUGH & NASAL CONGESTION Dextromethorphan Hydrobromide	10mg	—	🇦🇺 AU	Neo Health (OTC) Pty Ltd	Active
DURO-TUSS DEXTROMETHORPHAN DRY COUGH LIQUID FORTE dextromethorphan hydrobromide monohydrate	3 mg	—	🇦🇺 AU	iNova Pharmaceuticals Australia Pty Ltd	Active
Neodex Dry Cough Forte Dextromethorphan Hydrobromide monohydrate	15mg	—	🇦🇺 AU	Neo Health (OTC) Pty Ltd	Active
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	15; 6.25mg/5mL; mg/5mL	syrup	🇺🇸 US	Xttrium Laboratories, Inc	Active
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	2; 10; 30mg/5mL; mg/5mL; mg/5mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
ROBITUSSIN DRY COUGH FORTE dextromethorphan hydrobromide monohydrate	3 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
BISOLVON DRY dextromethorphan hydrobromide monohydrate	2mg	—	🇦🇺 AU	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Active
STREPSILS DRY COUGH LOZENGES dextromethorphan hydrobromide monohydrate	5mg	lozeng	🇦🇺 AU	Reckitt Benckiser Pty Ltd	Active
Vicks Formula	1.333mg	orl	🇦🇺 AU	Procter & Gamble Australia Pty Ltd	Active
VICKS COUGH SYRUP HONEY FLAVOUR DRY COUGH dextromethorphan hydrobromide monohydrate	1.333mg	orl	🇦🇺 AU	Procter & Gamble Australia Pty Ltd	Active
BISOLVON DRY HONEY LIME FLAVOUR dextromethorphan hydrobromide monohydrate	10.5 mg	—	🇦🇺 AU	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Active
MEDREICH Paracetamol	500 mg	—	🇦🇺 AU	Medreich Australia Pty Ltd	Active
Guaifenesin and Dextromethorphan Hydrobromide HBR	60; 1200mg/1; mg/1	tablet	🇺🇸 US	RITE-AID	Active
Dextromethorphan hydrobromide and quinidine sulfate	20; 10mg/1; mg/1	capsule	🇺🇸 US	Camber Pharmaceuticals, Inc.	Active
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	325; 15; 6.25mg/1; mg/1; mg/1	capsule	🇺🇸 US	SOFTGEL HEALTHCARE PRIVATE LIMITED	Active

+5 more registrations on file

Mederti Drug Report

Generated 4 July 2026 · Australia market · 4 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.