Quick answers
- What is Methacholine chloride inhalation solution used for?
- The FDA-approved label (Provocholine, Methapharm Inc., July 15, 2026) says: “Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methacholine chloride inhalation solution have a boxed warning?
- Yes. The FDA label for Provocholine has a boxed warning (“WARNING: SEVERE BRONCHOCONSTRICTION WARNING: SEVERE BRONCHOCONSTRICTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methacholine chloride inhalation solution?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methacholine chloride inhalation solution been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methacholine chloride inhalation solution?
- 1 company lists prescription products of Methacholine chloride inhalation solution in the FDA NDC Directory, including Methapharm Inc..
What Methacholine chloride inhalation solution is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. …
— FDA label: Provocholine, Methapharm Inc., effective July 15, 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SEVERE BRONCHOCONSTRICTION WARNING: SEVERE BRONCHOCONSTRICTION
. Read it on the full label →
Forms and how it is given
| Dosage forms | Solution · Powder, for solution |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Provocholine Inhalation Solution, Provocholine |
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.
- Methapharm Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019193 PROVOCHOLINE | Methapharm | October 31, 1986 | 14, latest June 6, 2026 2026: Labeling · 2022: Manufacturing (CMC) · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | e8983096-65e6-41f2-8b6f-bbf0a7227307 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA019193 |
| Active ingredients (FDA) | METHACHOLINE CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Provocholine, Methapharm Inc., effective July 15, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →