FDA.reportPublic FDA data

Helium

Product NDC
14961-005
11-digit product format
149610005
Labeler code
14961
Product ID
14961-005_471b4709-87ae-bd9d-e063-6394a90a4933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Haun Specialty Gases, Inc.
Application
NDA206826
Marketing category
NDA
Marketing start
2005-01-04
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
5e036b6f-95cf-4c9b-883a-12675015d475Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14961-005-01Helium73 L in 1 CYLINDERGAS7315
14961-005-02Helium344 L in 1 CYLINDERGAS34415
14961-005-03Helium589 L in 1 CYLINDERGAS58915

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14961-005HELIUM GAS [HAUN SPECIALTY GASES, INC.]14Current NDC, Legacy NDC, 3 package rows20241027_5e036b6f-95cf-4c9b-883a-12675015d475.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 · 2 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
ndc (product): 14961-005
HeliumHELIUMKeen Compressed Gas Co. Inc.8bb1e27a-6855-a7c1-e053-2995a90a261e2025-11-17Exact identifier
application applno (NDA): 206826
application number: NDA206826

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN5e036b6f-95cf-4c9b-883a-12675015d47515
310693helium 99 % Gas for InhalationSCD5e036b6f-95cf-4c9b-883a-12675015d47515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14961-005-011496100050173 L in 1 CYLINDER (14961-005-01) 73 l2005-01-040000-00-00NoNoCurrent
14961-005-0214961000502344 L in 1 CYLINDER (14961-005-02) 344 l2005-01-040000-00-00NoNoCurrent
14961-005-0314961000503589 L in 1 CYLINDER (14961-005-03) 589 l2005-01-040000-00-00NoNoCurrent