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Helium, Oxygen

Prescription NDA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Helium, Oxygen
Generic name
Helium, Oxygen
Dosage form
Gas
Route
Respiratory (Inhalation)
Marketing category
NDA AUTHORIZED GENERIC · NDA AG
Labeler
AIRGAS USA, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
12
Data completeness
46% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Helium 600 mL/L 997972 View
Helium 800 mL/L 997972 View
Oxygen 200 mL/L 312172 View
Oxygen 400 mL/L 312172 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gas
Route of administration
Respiratory (Inhalation)
Presentations
14

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205843
Application type
NDA · New Drug Application
Approval date
July 20, 2013
Sponsor
AIRGAS USA LLC
Products on application
1
Submissions recorded
1
Products approved under application 205843.
Product Trade name Form Strength Ingredient Status TE Flags
205843-001 HELIUM, USP GAS HELIUM Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 205843.
Type No. Action Status Date Review
Original application 1 Medical Gas Approved July 20, 2013 Standard

Review documents

  • 0 · Original application · October 2, 2015

Adverse event reports

Source: openFDA FAERS
48,982
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OXYGEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
11054-041-01 11054-041 AIRGAS USA, LLC 300 L in 1 CYLINDER (11054-041-01) October 14, 1997
11054-041-02 11054-041 AIRGAS USA, LLC 500 L in 1 CYLINDER (11054-041-02) October 14, 1997
11054-041-03 11054-041 AIRGAS USA, LLC 2260 L in 1 CYLINDER (11054-041-03) October 14, 1997
11054-041-04 11054-041 AIRGAS USA, LLC 4000 L in 1 CYLINDER (11054-041-04) October 14, 1997
11054-041-05 11054-041 AIRGAS USA, LLC 4500 L in 1 CYLINDER (11054-041-05) October 14, 1997
11054-042-01 11054-042 AIRGAS USA, LLC 300 L in 1 CYLINDER (11054-042-01) October 14, 1997
11054-042-02 11054-042 AIRGAS USA, LLC 500 L in 1 CYLINDER (11054-042-02) October 14, 1997
11054-042-03 11054-042 AIRGAS USA, LLC 2260 L in 1 CYLINDER (11054-042-03) October 14, 1997
11054-042-04 11054-042 AIRGAS USA, LLC 4000 L in 1 CYLINDER (11054-042-04) October 14, 1997
11054-042-05 11054-042 AIRGAS USA, LLC 4500 L in 1 CYLINDER (11054-042-05) October 14, 1997
11054-042-06 11054-042 AIRGAS USA, LLC 3539 L in 1 CYLINDER (11054-042-06) October 14, 1997
11054-042-07 11054-042 AIRGAS USA, LLC 5663 L in 1 CYLINDER (11054-042-07) October 14, 1997
11054-041 11054-041 AIRGAS USA, LLC — October 14, 1997
11054-042 11054-042 AIRGAS USA, LLC — October 14, 1997

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 8 sections on this page.