FDA.reportPublic FDA data

Helium

Product NDC
84120-001
11-digit product format
841200001
Labeler code
84120
Product ID
84120-001_40a9f139-f16f-bb51-e063-6294a90a5536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WSM SUPPLIER LLC.
Application
NDA205843
Marketing category
NDA
Marketing start
2024-05-07
Substance
HELIUM
Active strength
992 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
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
153317bb-7f55-0964-e063-6394a90a2922Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84120-001-01Helium377 L in 1 CYLINDERGAS3773
84120-001-02Helium623 L in 1 CYLINDERGAS6233
84120-001-03Helium2143 L in 1 CYLINDERGAS21433
84120-001-04Helium2899 L in 1 CYLINDERGAS28993
84120-001-05Helium5689 L in 1 CYLINDERGAS56893
84120-001-06Helium6201 L in 1 CYLINDERGAS62013
84120-001-07Helium6338 L in 1 CYLINDERGAS63383
84120-001-08Helium6824 L in 1 CYLINDERGAS68243
84120-001-09Helium7481 L in 1 CYLINDERGAS74813
84120-001-10Helium8144 L in 1 CYLINDERGAS81443
84120-001-11Helium762 L in 1 CYLINDERGAS7623

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84120-001HELIUM GAS [WSM SUPPLIER LLC.]2Current NDC, 11 package rows20241204_153317bb-7f55-0964-e063-6394a90a2922.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
ndc (product): 84120-001
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
84120-001-0184120000101377 L in 1 CYLINDER (84120-001-01) 377 l2024-05-07NoNoCurrent
84120-001-0284120000102623 L in 1 CYLINDER (84120-001-02) 623 l2024-05-07NoNoCurrent
84120-001-03841200001032143 L in 1 CYLINDER (84120-001-03) 2143 l2024-05-07NoNoCurrent
84120-001-04841200001042899 L in 1 CYLINDER (84120-001-04) 2899 l2024-05-07NoNoCurrent
84120-001-05841200001055689 L in 1 CYLINDER (84120-001-05) 5689 l2024-05-07NoNoCurrent
84120-001-06841200001066201 L in 1 CYLINDER (84120-001-06) 6201 l2024-05-07NoNoCurrent
84120-001-07841200001076338 L in 1 CYLINDER (84120-001-07) 6338 l2024-05-07NoNoCurrent
84120-001-08841200001086824 L in 1 CYLINDER (84120-001-08) 6824 l2024-05-07NoNoCurrent
84120-001-09841200001097481 L in 1 CYLINDER (84120-001-09) 7481 l2024-05-07NoNoCurrent
84120-001-10841200001108144 L in 1 CYLINDER (84120-001-10) 8144 l2024-05-07NoNoCurrent
84120-001-1184120000111762 L in 1 CYLINDER (84120-001-11) 762 l2024-05-07NoNoCurrent