FDA.reportPublic FDA data

Helium

Manufacturer
Roberts Oxygen Company, Inc.
Effective date
2025-11-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:46:19

Label at a glance#

ProductHelium
Active ingredientHELIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIUM,
COMPRESSED
USP
UN1046
NON-FLAMMABLE GAS 2
Rx ONLY. WARNING:Administration of Helium USP may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Helium USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. WARNING:CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventative device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52ºC (125ºF). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED:Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
CAS: 7440-59-7  DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO BOX 5507 Rockville, MD 20855
301-948-8100

image of cylinder labelimage of cylinder label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310693helium 99 % Gas for InhalationPSN7
310693helium 99 % Gas for InhalationSCD7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46123-008-012025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-022025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-032025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-042025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-052025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-062025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-072025-01-21C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-012022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-022022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-032022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-042022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-052022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-062022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800
46123-008-072022-01-28C16284748780-1d6a99b39-cc60-a426-e053-dadaa90af4c2Helium-800

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46123-800-01Helium102 L in 1 CYLINDERGAS1027
46123-800-02Helium374 L in 1 CYLINDERGAS3747
46123-800-03Helium623 L in 1 CYLINDERGAS6237
46123-800-04Helium3880 L in 1 CYLINDERGAS38807
46123-800-05Helium5436 L in 1 CYLINDERGAS54367
46123-800-06Helium6910 L in 1 CYLINDERGAS69107
46123-800-07Helium8241 L in 1 CYLINDERGAS82417

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB411
HeliumACTIVE MOIETY206GF3GB411

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46123-80046123-800-01, 46123-800-02, 46123-800-03, 46123-800-04, 46123-800-05, 46123-800-06, 46123-800-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELIUM206GF3GB41ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMRoberts Oxygen Company, Inc.554faa48-7fc2-4d1a-b223-82cf107b144f2025-11-17Exact identifier
ndc (package): 46123-800-06
ndc (package): 46123-800-04
ndc (package): 46123-800-07
ndc (package): 46123-800-02
ndc (package): 46123-800-01
ndc (package): 46123-800-03
ndc (package): 46123-800-05
ndc (product): 46123-800
ndc11 (package): 46123080003
ndc11 (package): 46123080005
ndc11 (package): 46123080001
ndc11 (package): 46123080006
ndc11 (package): 46123080007
ndc11 (package): 46123080004
ndc11 (package): 46123080002
spl id: 43cecff0-1ded-dece-e063-6394a90a8c6e
spl set id: 554faa48-7fc2-4d1a-b223-82cf107b144f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.