Fluocinonide shortage — US supply status & alternatives

Fluocinonide

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In supply · Australia

Topactin Cream 0.05% U.S.P

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA

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)	Fluocinonide
Brand names	Topactin Cream 0.05% U.S.P
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	TEVA PHARMACEUTICALS USA, INC., E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, SUN PHARMACEUTICAL INDUSTRIES, INC., Bryant Ranch Prepack

Registrations on file	4

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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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.

Other markets

🇺🇸 US

US$0.64

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

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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

4 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.

Moderate concentration risk

Farmabios SPATapi Nl BVTaro Pharmaceutical Industries LTDTianjin Tianyao Pharmaceuticals CO LTD

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

Recalls official enforcement reports

🇺🇸

FLUOCINONIDE

SUN PHARMACEUTICAL INDUSTRIES INC · Mar 2026

Class IIdetails ↗

🇺🇸

FLUOCINONIDE

SUN PHARMACEUTICAL INDUSTRIES INC · Mar 2026

Class IIdetails ↗

🇺🇸

FLUOCINONIDE

SUN PHARMACEUTICAL INDUSTRIES INC · Mar 2026

Class IIdetails ↗

🇺🇸

FLUOCINONIDE

Taro Pharmaceuticals U.S.A., Inc. · Sept 2017

Class IIIdetails ↗

🇺🇸

FLUOCINONIDE

Taro Pharmaceuticals U.S.A., Inc. · Mar 2017

Class IIIdetails ↗

🇺🇸

Fluocinonide

Synergy Rx · Feb 2017

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders4 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Fluocinonide	.5mg/g	cream	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
fluocinonide	.5mg/mL	solution	🇺🇸 US	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	Active
Fluocinonide	1mg/g	cream	🇺🇸 US	SUN PHARMACEUTICAL INDUSTRIES, INC.	Active
Fluocinonide	.05mg/g	ointment	🇺🇸 US	Bryant Ranch Prepack	Active

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.