FDA.reportPublic FDA data

Helium Oxygen mixture

Product NDC
11054-032
11-digit product format
110540032
Labeler code
11054
Product ID
11054-032_bb74f93c-30bd-4d5c-9663-cc4c840b9dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium Oxygen mixture
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Airgas Usa, LLC
Application
NDA205843
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-01-03
Substance
HELIUM; OXYGEN
Active strength
700; 300 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 mixture
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM700 mL/L
OXYGEN300 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
347048Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df74ce02-cbf4-49b3-8456-dc4fa7ddc9beAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-032-01Helium Oxygen mixture3539 L in 1 CYLINDERGAS35398
11054-032-02Helium Oxygen mixture5663 L in 1 CYLINDERGAS56638

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11054-032HELIUM OXYGEN MIXTURE GAS [AIRGAS USA, LLC]8Current NDC, Legacy NDC, 2 package rows20241004_df74ce02-cbf4-49b3-8456-dc4fa7ddc9be.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
Helium Oxygen mixtureHELIUM OXYGEN MIXTUREAirgas Usa, LLCdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 11054-032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347048helium 70 % / oxygen 30 % Gas for InhalationPSNdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be8
347048helium 70 % / oxygen 30 % Gas for InhalationSCDdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11054-032-01110540032013539 L in 1 CYLINDER (11054-032-01) 3539 l2012-01-030000-00-00NoNoCurrent
11054-032-02110540032025663 L in 1 CYLINDER (11054-032-02) 5663 l2012-01-030000-00-00NoNoCurrent