FDA.reportPublic FDA data

Helium

Product NDC
49575-200
Requested package NDC
49575-200-08
11-digit product format
495750200
Labeler code
49575
Product ID
49575-200_44ff0133-984c-f57e-e063-6294a90a5c73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Machine & Welding Supply Company dba Arc3 Gases South
Application
NDA211781
Marketing category
NDA
Marketing start
2022-02-01
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
44ff03e6-f79d-eb6c-e063-6294a90aba5bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49575-200-06Helium99.5 L in 1 CYLINDERGAS99.51
49575-200-07Helium144.4 L in 1 CYLINDERGAS144.41
49575-200-08Helium377 L in 1 CYLINDERGAS3771
49575-200-09Helium623 L in 1 CYLINDERGAS6231

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
HeliumHELIUMA-OX Welding Supply, LLC7046ef16-a4f4-15b7-e053-2a91aa0a4f1a2025-10-23Exact identifier
application applno (NDA): 211781
application number: NDA211781
HeliumHELIUMMachine & Welding Supply Company dba Arc3 Gases South44ff03e6-f79d-eb6c-e063-6294a90aba5b2024-12-06Exact identifier
application applno (NDA): 211781
application number: NDA211781
ndc (package): 49575-200-08
ndc (product): 49575-200
ndc11 (package): 49575020008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN44ff03e6-f79d-eb6c-e063-6294a90aba5b1
310693helium 99 % Gas for InhalationSCD44ff03e6-f79d-eb6c-e063-6294a90aba5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49575-200-0849575020008377 L in 1 CYLINDER (49575-200-08) 377 l2022-02-01NoNoCurrent