Nicotine Polacrilex — supply status, manufacturers & alternatives

Nicotine Polacrilex

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🇦🇺 AUST R 312582 · Johnson & Johnson Pacific Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇸🇬 SG

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)	Nicotine Polacrilex
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No

Registrations on file	16

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

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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.

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

7 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

Cambrex Charles City INCNicobrand LTDLaboratorios Haymann SAFertin Pharma AsSiegfried LTDBgp Healthcare Private LTD+1 more

Manufacturing countries: United States, United Kingdom, Denmark, Switzerland, India · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

CAREONE NICOTINE

Perrigo Holland Inc · Aug 2014

Class IIIdetails ↗

🇺🇸

NICORETTE

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Feb 2014

Class IIIdetails ↗

🇺🇸

NICORETTE

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Feb 2014

Class IIIdetails ↗

🇺🇸

NICORETTE

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Feb 2014

Class IIIdetails ↗

🇺🇸

NICORETTE

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Feb 2014

Class IIIdetails ↗

🇺🇸

Nicotine Polacrilex

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders16 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
NICORETTE nicotine	2 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICORETTE nicotine	4 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
HERRON NICAWAY LOZENGES, nicotine	2 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Pharmacy Care Nicotine Lozenges	2mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Pharmacy Care Nicotine Lozenges	4mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICORETTE nicotine	2mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICORETTE nicotine	4mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
HERRON NICAWAY LOZENGES, nicotine	4 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Amcal Nicotine Lozenges	2mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Amcal Nicotine Lozenges	4mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICOTINELL PEPPERMINT LOZENGES nicotine	2 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICOTINELL PEPPERMINT LOZENGES nicotine	4 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICORETTE FRUITDROPS nicotine	4mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICORETTE FRUITDROPS nicotine	2 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
Nicotine Polacrilex	2mg/1	gum,	🇺🇸 US	WALGREENS	Active

+1 more registration on file

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.