FDA.reportPublic FDA data

Helium, Oxygen

Product NDC
11054-041
Requested package NDC
11054-041-05
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11054-04111054-041-05DDiscontinued by firm2026-09-14

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM800 mL/L
OXYGEN200 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206GF3GB41Internal UNII lookup
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58ba729f-cca1-4e08-a131-dbe91258d99dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-041-01Helium, Oxygen300 L in 1 CYLINDERGAS3009
11054-041-02Helium, Oxygen500 L in 1 CYLINDERGAS5009
11054-041-03Helium, Oxygen2260 L in 1 CYLINDERGAS22609
11054-041-04Helium, Oxygen4000 L in 1 CYLINDERGAS40009
11054-041-05Helium, Oxygen4500 L in 1 CYLINDERGAS45009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11054-041HELIUM, OXYGEN GAS [AIRGAS USA, LLC]9Current NDC, Legacy NDC, 5 package rows20241004_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMWSM SUPPLIER LLC.153317bb-7f55-0964-e063-6394a90a29222025-10-08Exact identifier
application applno (NDA): 205843
application number: NDA205843
HELIUMHELIUMAIRGAS USA, LLC61d7bc2a-a22d-4640-99ee-9737d39d07fe2025-09-03Exact identifier
application applno (NDA): 205843
application number: NDA205843
HELIUMHELIUMAir Source Industries Inc7d1d5963-8b7f-4d8d-807a-6b9f896c71712024-10-06Exact identifier
application applno (NDA): 205843
application number: NDA205843
Helium, OxygenHELIUM, OXYGENAIRGAS USA, LLC8485f6f4-f322-4b82-abff-47e64c713f1b2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
Helium, OxygenHELIUM, OXYGENAIRGAS USA, LLC58ba729f-cca1-4e08-a131-dbe91258d99d2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (package): 11054-041-05
ndc (product): 11054-041
ndc11 (package): 11054004105
Helium Oxygen mixtureHELIUM OXYGEN MIXTUREAirgas Usa, LLCdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542169helium 80 % / oxygen 20 % Gas for InhalationPSN58ba729f-cca1-4e08-a131-dbe91258d99d9
542169helium 80 % / oxygen 20 % Gas for InhalationSCD58ba729f-cca1-4e08-a131-dbe91258d99d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11054-041-05110540041054500 L in 1 CYLINDER (11054-041-05) 4500 l1997-10-140000-00-00NoNoCurrent