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Helium Oxygen mixture

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 mixture

Generic name

Helium Oxygen mixture

Dosage form

Gas

Route

Respiratory (Inhalation)

Marketing category

—

Labeler

Linde Gas & Equipment Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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	700 mL/L	997972	View
Helium	800 mL/L	997972	View
Oxygen	200 mL/L	312172	View
Oxygen	300 mL/L	312172	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Gas

Route of administration

Respiratory (Inhalation)

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

205843

Application type

NDA · New Drug Application

Approval date

July 20, 2013

Sponsor

AIRGAS USA LLC

Products on application

Submissions recorded

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
11054-032-01	11054-032	Airgas Usa, LLC	3539 L in 1 CYLINDER (11054-032-01)	January 3, 2012
11054-032-02	11054-032	Airgas Usa, LLC	5663 L in 1 CYLINDER (11054-032-02)	January 3, 2012
59579-009-01	59579-009	Linde Gas & Equipment Inc.	7900 L in 1 CYLINDER (59579-009-01)	August 1, 2007
59579-009-02	59579-009	Linde Gas & Equipment Inc.	5975 L in 1 CYLINDER (59579-009-02)	August 1, 2007
59579-009-03	59579-009	Linde Gas & Equipment Inc.	2010 L in 1 CYLINDER (59579-009-03)	August 1, 2007
59579-009-04	59579-009	Linde Gas & Equipment Inc.	963 L in 1 CYLINDER (59579-009-04)	August 1, 2007
59579-009-05	59579-009	Linde Gas & Equipment Inc.	595 L in 1 CYLINDER (59579-009-05)	August 1, 2007
59579-009-06	59579-009	Linde Gas & Equipment Inc.	368 L in 1 CYLINDER (59579-009-06)	August 1, 2007
59579-009-07	59579-009	Linde Gas & Equipment Inc.	3086 L in 1 CYLINDER (59579-009-07)	September 1, 2020
59579-009-08	59579-009	Linde Gas & Equipment Inc.	509 L in 1 CYLINDER (59579-009-08)	September 1, 2020
59579-009-09	59579-009	Linde Gas & Equipment Inc.	3822 L in 1 CYLINDER (59579-009-09)	September 1, 2020
59579-009-10	59579-009	Linde Gas & Equipment Inc.	3822 L in 1 CYLINDER (59579-009-10)	September 1, 2020
59579-009-11	59579-009	Linde Gas & Equipment Inc.	623 L in 1 CYLINDER (59579-009-11)	September 1, 2020
11054-032	11054-032	Airgas Usa, LLC	—	January 3, 2012
59579-009	59579-009	Linde Gas & Equipment Inc.	—	August 1, 2007

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.