Prescription medicine
Nitrous oxide Brand names: Oxygen
Nitrous oxide (Oxygen) 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 nitrous oxide FDA label on DailyMed (effective December 2, 2025, Machine & Welding Supply Company dba Arc3 Gases South); the NDA 205704 record on Drugs@FDA; every nitrous oxide label on DailyMed.
Highlights of the record
FDA label of December 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 500 ml
- 900 ml
- 990 ml
- 992 ml
- 995 ml
Gas.
On the market
- Earliest approval on file
- June 16, 2013 Nitrous Oxide, Usp, Air Liquide America Speciality Gases; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 42 of which 0 under generic applications, 42 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
- 50,601 through July 30, 2026
Is there a generic for nitrous oxide (Oxygen)?
No generic nitrous oxide 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 does the nitrous oxide label say about other medicines?
The nitrous oxide label names no other medicine on this site. The labels of 21 other medicines name nitrous oxide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name nitrous oxide
Source: FDA drug label (Nitrous Oxide), Machine & Welding Supply Company dba Arc3 Gases South, effective December 2, 2025 (SPL set a5070767-c36a-4131-aa09-1bccfa24aa71), via openFDA; the full label on DailyMed
What do FAERS reports show for nitrous oxide?
The FDA Adverse Event Reporting System holds 50,601 reports that list nitrous oxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,333 are coded as a death and 21,572 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Nitrous oxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other