FDA.reportPublic FDA data

HELIUM

Product NDC
10167-300
Requested package NDC
10167-300-01
11-digit product format
101670300
Labeler code
10167
Product ID
10167-300_bbffc3c2-c49f-4215-8e74-0a2e7a92e3cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HELIUM
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Air Source Industries Inc
Application
NDA205843
Marketing category
NDA
Marketing start
1992-01-01
Substance
HELIUM
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM99 L/100L

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
310693Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d1d5963-8b7f-4d8d-807a-6b9f896c7171Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10167-300-01HELIUM610 L in 1 CYLINDERGAS61012
10167-300-02HELIUM5800 L in 1 CYLINDERGAS580012
10167-300-03HELIUM6160 L in 1 CYLINDERGAS616012
10167-300-04HELIUM161 L in 1 CYLINDERGAS16112
10167-300-05HELIUM166 L in 1 CYLINDERGAS16612
10167-300-06HELIUM370 L in 1 CYLINDERGAS37012
10167-300-07HELIUM2780 L in 1 CYLINDERGAS278012
10167-300-08HELIUM1557 L in 1 CYLINDERGAS155712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HELIUMACTIVE INGREDIENT206GF3GB41HELIUM GAS [AIR SOURCE INDUSTRIES INC]2
HELIUMACTIVE MOIETY206GF3GB41HELIUM GAS [AIR SOURCE INDUSTRIES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10167-300HELIUM GAS [AIR SOURCE INDUSTRIES INC]12Current NDC, Legacy NDC, 8 package rows20241008_7d1d5963-8b7f-4d8d-807a-6b9f896c7171.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
ndc (package): 10167-300-01
ndc (product): 10167-300
ndc11 (package): 10167030001
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
310693helium 99 % Gas for InhalationPSN7d1d5963-8b7f-4d8d-807a-6b9f896c717112
310693helium 99 % Gas for InhalationSCD7d1d5963-8b7f-4d8d-807a-6b9f896c717112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10167-300-0110167030001610 L in 1 CYLINDER (10167-300-01) 610 l1992-01-010000-00-00NoNoCurrent