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Prescription medicine

Glycopyrronium

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Glycopyrronium used for?
The FDA-approved label (Qbrexza, Journey Medical Corporation, May 21, 2026) says: “Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Glycopyrronium have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Glycopyrronium?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Glycopyrronium been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Glycopyrronium?
1 company lists prescription products of Glycopyrronium in the FDA NDC Directory, including Journey Medical Corporation.

What Glycopyrronium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

— FDA label: Qbrexza, Journey Medical Corporation, effective May 21, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsCloth
RouteTopical
Prescription products1 in the FDA NDC Directory
Brand namesQbrexza

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA210361
QBREXZA
JourneyJune 28, 2018 2, latest October 28, 2022
2022: Labeling · 2020: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)2054118, 2054120
SPL set ID of the quoted label5b372650-e56e-47a5-93e2-c0c292017059
FDA labels (SPL)1
FDA applicationsNDA210361
Active ingredients (FDA)GLYCOPYRRONIUM

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Qbrexza, Journey Medical Corporation, effective May 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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