Helium, Oxygen

Product NDC: 11054-041
11-digit product format: 110540041
Labeler code: 11054
Product ID: 11054-041_33379203-e590-4023-ad77-9da6775d4624
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Helium, Oxygen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: AIRGAS USA, LLC
Application: NDA205843
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1997-10-14
Substance: HELIUM; OXYGEN
Active strength: 800; 200 mL/L; mL/L
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11054-041		D	Discontinued by firm	2026-08-17
excluded package	package	11054-041	11054-041-01	D	Discontinued by firm	2026-08-17
excluded package	package	11054-041	11054-041-02	D	Discontinued by firm	2026-08-17
excluded package	package	11054-041	11054-041-03	D	Discontinued by firm	2026-08-17
excluded package	package	11054-041	11054-041-04	D	Discontinued by firm	2026-08-17
excluded package	package	11054-041	11054-041-05	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11054-041-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11054-041-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11054-041-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11054-041-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11054-041-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11054-041-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11054-041-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11054-041-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11054-041-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11054-041-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11054-041-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11054-041-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11054-041-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11054-041-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11054-041-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11054-041-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11054-041-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11054-041-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11054-041-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11054-041-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11054-041-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11054-041-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11054-041-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11054-041-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11054-041-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11054-041-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11054-041-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11054-041-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11054-041-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11054-041-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11054-041-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11054-041-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11054-041-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11054-041-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11054-041-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11054-041-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11054-041-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11054-041-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11054-041-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11054-041-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11054-041-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11054-041-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11054-041-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11054-041-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11054-041-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11054-041-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11054-041-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11054-041-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11054-041-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11054-041-03	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: Helium, Oxygen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HELIUM	800 mL/L
OXYGEN	200 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206GF3GB41	Internal UNII lookup
S88TT14065	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
542169	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58ba729f-cca1-4e08-a131-dbe91258d99d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11054-041-01	Helium, Oxygen	300 L in 1 CYLINDER	GAS	300	9
11054-041-02	Helium, Oxygen	500 L in 1 CYLINDER	GAS	500	9
11054-041-03	Helium, Oxygen	2260 L in 1 CYLINDER	GAS	2260	9
11054-041-04	Helium, Oxygen	4000 L in 1 CYLINDER	GAS	4000	9
11054-041-05	Helium, Oxygen	4500 L in 1 CYLINDER	GAS	4500	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11054-041	HELIUM, OXYGEN GAS [AIRGAS USA, LLC]	9	Current NDC, Legacy NDC, 5 package rows	20241004_58ba729f-cca1-4e08-a131-dbe91258d99d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Helium	HELIUM	WSM SUPPLIER LLC.	153317bb-7f55-0964-e063-6394a90a2922	2025-10-08	Exact identifier application applno (NDA): 205843 application number: NDA205843
HELIUM	HELIUM	AIRGAS USA, LLC	61d7bc2a-a22d-4640-99ee-9737d39d07fe	2025-09-03	Exact identifier application applno (NDA): 205843 application number: NDA205843
HELIUM	HELIUM	Air Source Industries Inc	7d1d5963-8b7f-4d8d-807a-6b9f896c7171	2024-10-06	Exact identifier application applno (NDA): 205843 application number: NDA205843
Helium, Oxygen	HELIUM, OXYGEN	AIRGAS USA, LLC	8485f6f4-f322-4b82-abff-47e64c713f1b	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843
Helium, Oxygen	HELIUM, OXYGEN	AIRGAS USA, LLC	58ba729f-cca1-4e08-a131-dbe91258d99d	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843 ndc (product): 11054-041
Helium Oxygen mixture	HELIUM OXYGEN MIXTURE	Airgas Usa, LLC	df74ce02-cbf4-49b3-8456-dc4fa7ddc9be	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
206GF3GB41	HELIUM	7440-59-7	HELIUM
S88TT14065	OXYGEN	7782-44-7	OXYGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
542169	helium 80 % / oxygen 20 % Gas for Inhalation	PSN	58ba729f-cca1-4e08-a131-dbe91258d99d	9
542169	helium 80 % / oxygen 20 % Gas for Inhalation	SCD	58ba729f-cca1-4e08-a131-dbe91258d99d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11054-041-01	11054004101	300 L in 1 CYLINDER (11054-041-01)	300 l	1997-10-14	0000-00-00	No	No	Current
11054-041-02	11054004102	500 L in 1 CYLINDER (11054-041-02)	500 l	1997-10-14	0000-00-00	No	No	Current
11054-041-03	11054004103	2260 L in 1 CYLINDER (11054-041-03)	2260 l	1997-10-14	0000-00-00	No	No	Current
11054-041-04	11054004104	4000 L in 1 CYLINDER (11054-041-04)	4000 l	1997-10-14	0000-00-00	No	No	Current
11054-041-05	11054004105	4500 L in 1 CYLINDER (11054-041-05)	4500 l	1997-10-14	0000-00-00	No	No	Current