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Prescription medicine

Nitrous oxide

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

Does Nitrous oxide have a boxed warning?
No. None of the 35 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Nitrous oxide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Nitrous oxide been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Nitrous oxide?
42 companies list prescription products of Nitrous oxide in the FDA NDC Directory, including Roberts Oxygen Company, Inc., NexAir, LLC and AGL Welding Supply Co., Inc..

What Nitrous oxide 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 35 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsGas
RouteRespiratory (inhalation)
Prescription products44 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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA205704
NITROUS OXIDE, USP
Air Liquide America Speciality GasesJune 16, 2013 —
NDA206009
NITROUS OXIDE, USP
Nitrous Oxide CorpSeptember 3, 2013 —
NDA206014
NITROUS OXIDE, USP
Nitrous Oxide of CanadaSeptember 6, 2013 —
NDA209989
NITROUS OXIDE, USP
Matheson Tri-Gas IncJanuary 9, 2017 —

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)312022, 347046, 347166
SPL set ID of the quoted label07aa2a86-d01e-470f-a12c-9908118bedc6
FDA labels (SPL)35
FDA applicationsNDA205704, NDA206009, NDA206014, NDA209989
Active ingredients (FDA)NITROUS OXIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Nitrous Oxide, American Welding & Gas, effective October 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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