FDA.reportPublic FDA data

HELIUM

Product NDC
11054-004
Requested package NDC
11054-004-09
11-digit product format
110540004
Labeler code
11054
Product ID
11054-004_96b7c3dd-828b-497e-80b8-ce6caf8cb9f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HELIUM
Dosage form
GAS
Route
INTRACORONARY; RESPIRATORY (INHALATION)
Labeler
AIRGAS USA, LLC
Application
NDA205843
Marketing category
NDA
Marketing start
1997-11-06
Substance
HELIUM
Active strength
992 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 packagepackage11054-00411054-004-09DDiscontinued by firm2026-08-17

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 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.

Additional Listing Data#

Finished product
Yes
Brand name base
HELIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM992 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997972Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61d7bc2a-a22d-4640-99ee-9737d39d07feAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-004-01HELIUM99 L in 1 CYLINDERGAS99530
11054-004-02HELIUM148 L in 1 CYLINDERGAS148530
11054-004-03HELIUM144 L in 1 CYLINDERGAS144530
11054-004-04HELIUM181 L in 1 CYLINDERGAS181530
11054-004-05HELIUM215 L in 1 CYLINDERGAS215530
11054-004-06HELIUM359 L in 1 CYLINDERGAS359530
11054-004-07HELIUM448 L in 1 CYLINDERGAS448530
11054-004-08HELIUM566 L in 1 CYLINDERGAS566530
11054-004-09HELIUM590 L in 1 CYLINDERGAS590530
11054-004-10HELIUM1508 L in 1 CYLINDERGAS1508530
11054-004-11HELIUM3022 L in 1 CYLINDERGAS3022530
11054-004-12HELIUM177 L in 1 CYLINDERGAS177530
11054-004-13HELIUM183 L in 1 CYLINDERGAS183530
11054-004-14HELIUM204 L in 1 CYLINDERGAS204530
11054-004-15HELIUM354 L in 1 CYLINDERGAS354530
11054-004-16HELIUM367 L in 1 CYLINDERGAS367530
11054-004-17HELIUM408 L in 1 CYLINDERGAS408530
11054-004-18HELIUM459 L in 1 CYLINDERGAS459530
11054-004-19HELIUM511 L in 1 CYLINDERGAS511530
11054-004-20HELIUM577 L in 1 CYLINDERGAS577530
11054-004-21HELIUM598 L in 1 CYLINDERGAS598530
11054-004-22HELIUM666 L in 1 CYLINDERGAS666530
11054-004-23HELIUM1021 L in 1 CYLINDERGAS1021530
11054-004-24HELIUM1137 L in 1 CYLINDERGAS1137530
11054-004-25HELIUM1397 L in 1 CYLINDERGAS1397530
11054-004-26HELIUM1555 L in 1 CYLINDERGAS1555530
11054-004-27HELIUM2105 L in 1 CYLINDERGAS2105530
11054-004-28HELIUM2344 L in 1 CYLINDERGAS2344530
11054-004-29HELIUM2835 L in 1 CYLINDERGAS2835530
11054-004-30HELIUM3120 L in 1 CYLINDERGAS3120530
11054-004-31HELIUM3460 L in 1 CYLINDERGAS3460530
11054-004-32HELIUM3853 L in 1 CYLINDERGAS3853530
11054-004-33HELIUM4762 L in 1 CYLINDERGAS4762530
11054-004-34HELIUM5664 L in 1 CYLINDERGAS5664530
11054-004-35HELIUM6570 L in 1 CYLINDERGAS6570530
11054-004-36HELIUM5503 L in 1 CYLINDERGAS5503530
11054-004-37HELIUM6202 L in 1 CYLINDERGAS6202530
11054-004-38HELIUM6370 L in 1 CYLINDERGAS6370530
11054-004-39HELIUM6910 L in 1 CYLINDERGAS6910530
11054-004-40HELIUM8009 L in 1 CYLINDERGAS8009530
11054-004-41HELIUM8210 L in 1 CYLINDERGAS8210530
11054-004-42HELIUM10685 L in 1 CYLINDERGAS10685530
11054-004-43HELIUM10860 L in 1 CYLINDERGAS10860530

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11054-004HELIUM GAS [AIRGAS USA, LLC]529Current NDC, Legacy NDC, 43 package rows20241004_61d7bc2a-a22d-4640-99ee-9737d39d07fe.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
ndc (package): 11054-004-09
ndc (product): 11054-004
ndc11 (package): 11054000409
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997972helium 99.2 % Gas for InhalationPSN61d7bc2a-a22d-4640-99ee-9737d39d07fe530
997972helium 99.2 % Gas for InhalationSCD61d7bc2a-a22d-4640-99ee-9737d39d07fe530
997972helium 99.2 % Gas for InhalationPSN153317bb-7f55-0964-e063-6394a90a29223
997972helium 99.2 % Gas for InhalationSCD153317bb-7f55-0964-e063-6394a90a29223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11054-004-0911054000409590 L in 1 CYLINDER (11054-004-09) 590 l1997-11-060000-00-00NoNoCurrent