Quick answers
- What is Alcohol used for?
- The FDA-approved label (Dehydrated Alcohol, BPI Labs, LLC, January 5, 2026) says: “ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alcohol have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alcohol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated May 27, 2026). Ask your pharmacist about alternatives.
- Has Alcohol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alcohol?
- 8 companies list prescription products of Alcohol in the FDA NDC Directory, including BPI Labs LLC, A-S Medication Solutions and Solupharm Pharmazeutische Erzeugnisse GmbH.
What Alcohol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. …
— FDA label: Dehydrated Alcohol, BPI Labs, LLC, effective January 5, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Percutaneous · Intra-arterial |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Dehydrated Alcohol |
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.
- BPI Labs LLC2 products
- A-S Medication Solutions1 product
- Solupharm Pharmazeutische Erzeugnisse GmbH1 product
- Accord Healthcare Inc.1 product
- Breckenridge Pharmaceutical, Inc.1 product
- Avenacy, LLC1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Ajenat Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207987 ABLYSINOL | Bpi Labs | June 21, 2018 | 1, latest March 3, 2025 2025: Manufacturing (CMC) |
Generic approvals (4)
- ANDA217845Accord Hlthcare · June 23, 2025
- ANDA219400Xgen Pharms · June 23, 2025
- ANDA219444Breckenridge · June 23, 2025
- ANDA219569Ingenus Pharms LLC · July 9, 2025
Shortage status
To be discontinued · updated May 27, 2026 · first posted May 27, 2026
| Product | Dehydrated Alcohol, Injection, Solution, 1 mL/1 mL (10 pack) (NDC 16729-710-45) |
|---|---|
| Company | Accord Healthcare Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2048979, 2048982 |
|---|---|
| SPL set ID of the quoted label | 314b1dab-8f4f-49ae-a105-f974842818b8 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA207987, 4 ANDA |
| Active ingredients (FDA) | ALCOHOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dehydrated Alcohol, BPI Labs, LLC, effective January 5, 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 →