FDA.reportPublic FDA data

Helium, Oxygen

Product NDC
11054-042
11-digit product format
110540042
Labeler code
11054
Product ID
11054-042_1e2d5059-5d8c-41d3-a45e-49b945b7ae8a
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
600; 400 mL/L; mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
IngredientStrength
HELIUM600 mL/L
OXYGEN400 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
347697Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8485f6f4-f322-4b82-abff-47e64c713f1bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-042-01Helium, Oxygen300 L in 1 CYLINDERGAS3008
11054-042-02Helium, Oxygen500 L in 1 CYLINDERGAS5008
11054-042-03Helium, Oxygen2260 L in 1 CYLINDERGAS22608
11054-042-04Helium, Oxygen4000 L in 1 CYLINDERGAS40008
11054-042-05Helium, Oxygen4500 L in 1 CYLINDERGAS45008
11054-042-06Helium, Oxygen3539 L in 1 CYLINDERGAS35398
11054-042-07Helium, Oxygen5663 L in 1 CYLINDERGAS56638

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11054-042HELIUM, OXYGEN GAS [AIRGAS USA, LLC]8Current NDC, Legacy NDC, 7 package rows20241004_8485f6f4-f322-4b82-abff-47e64c713f1b.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
ndc (product): 11054-042
Helium, OxygenHELIUM, OXYGENAIRGAS USA, LLC58ba729f-cca1-4e08-a131-dbe91258d99d2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
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
347697helium 60 % / oxygen 40 % Gas for InhalationPSN8485f6f4-f322-4b82-abff-47e64c713f1b8
347697helium 60 % / oxygen 40 % Gas for InhalationSCD8485f6f4-f322-4b82-abff-47e64c713f1b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11054-042-0111054004201300 L in 1 CYLINDER (11054-042-01) 300 l1997-10-140000-00-00NoNoCurrent
11054-042-0211054004202500 L in 1 CYLINDER (11054-042-02) 500 l1997-10-140000-00-00NoNoCurrent
11054-042-03110540042032260 L in 1 CYLINDER (11054-042-03) 2260 l1997-10-140000-00-00NoNoCurrent
11054-042-04110540042044000 L in 1 CYLINDER (11054-042-04) 4000 l1997-10-140000-00-00NoNoCurrent
11054-042-05110540042054500 L in 1 CYLINDER (11054-042-05) 4500 l1997-10-140000-00-00NoNoCurrent
11054-042-06110540042063539 L in 1 CYLINDER (11054-042-06) 3539 l1997-10-140000-00-00NoNoCurrent
11054-042-07110540042075663 L in 1 CYLINDER (11054-042-07) 5663 l1997-10-140000-00-00NoNoCurrent