Quick answers
- Does Helium have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Helium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Helium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Helium?
- 16 companies list prescription products of Helium in the FDA NDC Directory, including Machine & Welding Supply Company dba Arc3 Gases South, NexAir, LLC and WSM Supplier LLC..
What Helium is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine. See the 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.
0 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gas |
|---|---|
| Route | Respiratory (inhalation) · Intracoronary |
| Prescription products | 16 in the FDA NDC Directory |
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.
- Machine & Welding Supply Company dba Arc3 Gases South1 product
- NexAir, LLC1 product
- WSM Supplier LLC.1 product
- Matheson Tri-Gas, Inc.1 product
- Linde Gas & Equipment Inc.1 product
- Air Source Industries Inc1 product
- AGL Inhalation Therapy Co.1 product
- Norco, Inc1 product
- Keen Compressed Gas Co. Inc.1 product
- ILMO Products Company1 product
- Aero All Gas Company1 product
- A-OX Welding Supply, LLC1 product
- Roberts Oxygen Company, Inc.1 product
- Haun Specialty Gases, Inc.1 product
- Airgas USA, LLC1 product
- General Air Service & Supply Co1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA205819 HELIUM, USP | Norco Inc | July 14, 2013 | — |
| NDA205843 HELIUM, USP | Airgas USA LLC | July 20, 2013 | — |
| NDA205912 HELIUM, USP | Praxair Distribution Inc | August 5, 2013 | — |
| NDA206826 HELIUM, USP | Linde Gas North America LLC | March 4, 2014 | — |
| NDA209033 HELIUM, USP | Nexair LLC | February 20, 2016 | — |
| NDA211781 HELIUM, USP | A-Ox Welding Supply Co, Inc. | April 23, 2018 | — |
| NDA212539 HELIUM, USP | Matheson Tri-Gas Inc | October 16, 2018 | — |
| NDA213609 HELIUM, USP | Roberts Oxygen Co Inc | July 14, 2019 | — |
| NDA213990 HELIUM, USP | ILMO Products Company | October 27, 2019 | — |
| NDA216307 HELIUM, USP | General Air Service & Supply Company | July 26, 2021 | — |
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
| RxCUI (RxNorm) | 310693, 347675, 997972 |
|---|---|
| SPL set ID of the quoted label | cb33fc07-e122-4f66-aa43-b659ee150150 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA205819, NDA205843, NDA205912, NDA206826, NDA209033, NDA211781, NDA212539, NDA213609, NDA213990, NDA216307 |
| Active ingredients (FDA) | HELIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Helium, NexAir, LLC, effective May 22, 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 →