FDA.reportPublic FDA data

Helium

Product NDC
10014-004
11-digit product format
100140004
Labeler code
10014
Product ID
10014-004_423c7fd0-edce-be76-e063-6394a90a68d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Aero All Gas Company
Application
NDA206826
Marketing category
NDA
Marketing start
1972-10-06
Substance
HELIUM
Active strength
990 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.

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
HELIUM990 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
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
2e9012ae-8ff1-4858-a1e9-e2c3959b2f57Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10014-004-10Helium623 L in 1 CYLINDERGAS62315
10014-004-11Helium3115 L in 1 CYLINDERGAS311515
10014-004-12Helium6202 L in 1 CYLINDERGAS620215
10014-004-13Helium7561 L in 1 CYLINDERGAS756115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [AERO ALL GAS COMPANY]3
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [AERO ALL GAS COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10014-004HELIUM GAS [AERO ALL GAS COMPANY]14Current NDC, Legacy NDC, 4 package rows20241012_2e9012ae-8ff1-4858-a1e9-e2c3959b2f57.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMHaun Specialty Gases, Inc.5e036b6f-95cf-4c9b-883a-12675015d4752025-12-29Exact identifier
application applno (NDA): 206826
application number: NDA206826
HeliumHELIUMKeen Compressed Gas Co. Inc.8bb1e27a-6855-a7c1-e053-2995a90a261e2025-11-17Exact identifier
application applno (NDA): 206826
application number: NDA206826
HeliumHELIUMAero All Gas Company2e9012ae-8ff1-4858-a1e9-e2c3959b2f572025-10-28Exact identifier
application applno (NDA): 206826
application number: NDA206826
ndc (product): 10014-004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN2e9012ae-8ff1-4858-a1e9-e2c3959b2f5715
310693helium 99 % Gas for InhalationSCD2e9012ae-8ff1-4858-a1e9-e2c3959b2f5715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10014-004-1010014000410623 L in 1 CYLINDER (10014-004-10) 623 l1972-10-060000-00-00NoNoCurrent
10014-004-11100140004113115 L in 1 CYLINDER (10014-004-11) 3115 l1972-10-060000-00-00NoNoCurrent
10014-004-12100140004126202 L in 1 CYLINDER (10014-004-12) 6202 l1972-10-060000-00-00NoNoCurrent
10014-004-13100140004137561 L in 1 CYLINDER (10014-004-13) 7561 l1972-10-060000-00-00NoNoCurrent