Prescription medicine
Helium
Helium is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the helium FDA label on DailyMed (effective May 22, 2026, NexAir, LLC); the NDA 205819 record on Drugs@FDA; every helium label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 990 ml
- 992 ml
- 999 ml
Gas.
On the market
- Earliest approval on file
- July 14, 2013 Helium, Usp, Norco Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 16 of which 0 under generic applications, 16 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 50 through July 30, 2026
Is there a generic for helium?
No generic helium is approved (Drugs@FDA, October 8, 2026).
- 2013 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for helium?
The FDA Adverse Event Reporting System holds 50 reports that list helium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 33 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Helium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other