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Heliox
Heliox is a prescription drug, made by 2 manufacturers.
- Type
- Prescription
- Drug class
- Not classified
- Route
- Respiratory (Inhalation)
- Manufacturers
- 2
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrug11/22/2023Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f)...Family Medical Supply Inc · cGMP Deviations
- Class IIDrug05/05/2021Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C...Grace Healthcare Medical, Inc · cGMP deviations
- Class IIDrug03/20/2019Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b)...Roberts Home Medical LLC · CGMP Deviations
- Class IIDrug08/16/2017Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ...AtHome Medical, Inc. · GMP Deviations: The firm does not include an SOP for testing for...
- Class IIDrug08/10/2016Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL)...Let's Talk Health, Inc. · Marketed Without An Approved NDA/ANDA: product is an unapproved...
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Gas | 200 mL/L | respiratory (inhalation) | 2 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 38 reports that list heliox, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective18
- Condition aggravated5
- Off label use5
- Dyspnea4
- Agranulocytosis3
- Dermatitis bullous3
- Hypoxia3
- Maternal exposure during pregnancy3
- Pneumonia3
- Acute kidney injury2
To report a side effect, use FDA MedWatch.
Manufacturers and labels
2 FDA labels
- A-OX Welding Supply, LLCShown hereNDA205767 · Label 10/23/2025 · NDC 10297-080Full label
- Metro Welding Supply CorporationNDA205849 · Label 10/20/2025 · NDC 62273-007Full label
Heliox: common questions
- Is Heliox a prescription drug?
- Yes. Heliox is a prescription (Rx) drug.
- Are there other products with the same active ingredient as Heliox?
- Yes. Other FDA-listed products with the same active ingredients include Air Compressed, Reconstituted Air, Oxygen Nitrogen Mixture, Nitrogen Oxygen Mix.
- Who makes Heliox?
- 2 manufacturers list Heliox with the FDA, including A-OX Welding Supply, LLC, Metro Welding Supply Corporation.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/23/2025 · Label text is shown as published by the manufacturer. Not medical advice