FDA.reportPublic FDA data

HELIUM

Manufacturer
AIRGAS USA, LLC
Effective date
2025-09-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
530
Source
full-release
Hydrated at
2026-05-31 21:41:54

Label at a glance#

ProductHELIUM
Active ingredientHELIUM
Label structure2 sections

Label contents#

Full prescribing information#

HELIUM COMPRESSED USP SL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIUM,

COMPRESSED

USP

UN1046

DO NOT REMOVE THIS PRODUCT LABEL

NON-FLAMMABLE GAS 2

836580 (07/16)

WARNING: CONTAINS GAS UNDER PRESSURE. MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. INHALING HELIUM TO ALTER THE VOICE CAN BE FATAL. Use and store only outdoors or in a well ventilated place. Protect from sunlight when the ambient temperature exceeds 52°C/125°F. Use only with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortabe for breathing. Get medical advice/attention.

Rx only

WARNING: Administration of Helium 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 and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.

CAS: 7440-59-7

AIRGAS HEALTHCARE

an Air Liquide Company

AIRGAS USA, LLC
Radnor, PA 19087-5283

Safety Data Sheets available at www.airgas.com

AG HeliumAG Helium

HELIUM COMPRESSED USP body label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIUM,

COMPRESSED

USP

UN1046

NON-FLAMMABLE GAS 2

Rx only

WARNING: Administration of Helium 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 and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with 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. INHALING HELIUM TO ALTER THE VOICE CAN BE FATAL.

Use and store only outdoors or in a well ventilated place. Protect from sunlight when the ambient temperature exceeds 52°C/125°F. Use only with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortabe for breathing. Get medical advice/attention.

CAS: 7440-59-7

DO NOT REMOVE THIS PRODUCT LABEL

AIRGAS HEALTHCARE

an Air Liquide Company

AIRGAS USA, LLC
Radnor, PA 19087-5283

Safety Data Sheets available at www.airgas.com

Form 850301 (R 06/16)

AG HeliumAG Helium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997972helium 99.2 % Gas for InhalationPSN530
997972helium 99.2 % Gas for InhalationSCD530

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-004-01HELIUM99 L in 1 CYLINDERGAS99530
11054-004-02HELIUM148 L in 1 CYLINDERGAS148530
11054-004-03HELIUM144 L in 1 CYLINDERGAS144530
11054-004-04HELIUM181 L in 1 CYLINDERGAS181530
11054-004-05HELIUM215 L in 1 CYLINDERGAS215530
11054-004-06HELIUM359 L in 1 CYLINDERGAS359530
11054-004-07HELIUM448 L in 1 CYLINDERGAS448530
11054-004-08HELIUM566 L in 1 CYLINDERGAS566530
11054-004-09HELIUM590 L in 1 CYLINDERGAS590530
11054-004-10HELIUM1508 L in 1 CYLINDERGAS1508530
11054-004-11HELIUM3022 L in 1 CYLINDERGAS3022530
11054-004-12HELIUM177 L in 1 CYLINDERGAS177530
11054-004-13HELIUM183 L in 1 CYLINDERGAS183530
11054-004-14HELIUM204 L in 1 CYLINDERGAS204530
11054-004-15HELIUM354 L in 1 CYLINDERGAS354530
11054-004-16HELIUM367 L in 1 CYLINDERGAS367530
11054-004-17HELIUM408 L in 1 CYLINDERGAS408530
11054-004-18HELIUM459 L in 1 CYLINDERGAS459530
11054-004-19HELIUM511 L in 1 CYLINDERGAS511530
11054-004-20HELIUM577 L in 1 CYLINDERGAS577530
11054-004-21HELIUM598 L in 1 CYLINDERGAS598530
11054-004-22HELIUM666 L in 1 CYLINDERGAS666530
11054-004-23HELIUM1021 L in 1 CYLINDERGAS1021530
11054-004-24HELIUM1137 L in 1 CYLINDERGAS1137530
11054-004-25HELIUM1397 L in 1 CYLINDERGAS1397530
11054-004-26HELIUM1555 L in 1 CYLINDERGAS1555530
11054-004-27HELIUM2105 L in 1 CYLINDERGAS2105530
11054-004-28HELIUM2344 L in 1 CYLINDERGAS2344530
11054-004-29HELIUM2835 L in 1 CYLINDERGAS2835530
11054-004-30HELIUM3120 L in 1 CYLINDERGAS3120530
11054-004-31HELIUM3460 L in 1 CYLINDERGAS3460530
11054-004-32HELIUM3853 L in 1 CYLINDERGAS3853530
11054-004-33HELIUM4762 L in 1 CYLINDERGAS4762530
11054-004-34HELIUM5664 L in 1 CYLINDERGAS5664530
11054-004-35HELIUM6570 L in 1 CYLINDERGAS6570530
11054-004-36HELIUM5503 L in 1 CYLINDERGAS5503530
11054-004-37HELIUM6202 L in 1 CYLINDERGAS6202530
11054-004-38HELIUM6370 L in 1 CYLINDERGAS6370530
11054-004-39HELIUM6910 L in 1 CYLINDERGAS6910530
11054-004-40HELIUM8009 L in 1 CYLINDERGAS8009530
11054-004-41HELIUM8210 L in 1 CYLINDERGAS8210530
11054-004-42HELIUM10685 L in 1 CYLINDERGAS10685530
11054-004-43HELIUM10860 L in 1 CYLINDERGAS10860530

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
11054-00411054-004-01, 11054-004-02, 11054-004-03, 11054-004-04, 11054-004-05, 11054-004-06, 11054-004-07, 11054-004-08, 11054-004-09, 11054-004-10, 11054-004-11, 11054-004-12, 11054-004-13, 11054-004-14, 11054-004-15, 11054-004-16, 11054-004-17, 11054-004-18, 11054-004-19, 11054-004-20, 11054-004-21, 11054-004-22, 11054-004-23, 11054-004-24, 11054-004-25, 11054-004-26, 11054-004-27, 11054-004-28, 11054-004-29, 11054-004-30, 11054-004-31, 11054-004-32, 11054-004-33, 11054-004-34, 11054-004-35, 11054-004-36, 11054-004-37, 11054-004-38, 11054-004-39, 11054-004-40, 11054-004-41, 11054-004-42, 11054-004-43

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
HELIUMHELIUMAIRGAS USA, LLC61d7bc2a-a22d-4640-99ee-9737d39d07fe2025-09-03Exact identifier
ndc (package): 11054-004-41
ndc (package): 11054-004-20
ndc (package): 11054-004-38
ndc (package): 11054-004-21
ndc (package): 11054-004-32
ndc (package): 11054-004-19
ndc (package): 11054-004-11
ndc (package): 11054-004-42
ndc (package): 11054-004-37
ndc (package): 11054-004-30
ndc (package): 11054-004-01
ndc (package): 11054-004-03
ndc (package): 11054-004-14
ndc (package): 11054-004-29
ndc (package): 11054-004-02
ndc (package): 11054-004-31
ndc (package): 11054-004-35
ndc (package): 11054-004-10
ndc (package): 11054-004-24
ndc (package): 11054-004-17
ndc (package): 11054-004-12
ndc (package): 11054-004-26
ndc (package): 11054-004-34
ndc (package): 11054-004-15
ndc (package): 11054-004-07
ndc (package): 11054-004-27
ndc (package): 11054-004-09
ndc (package): 11054-004-33
ndc (package): 11054-004-23
ndc (package): 11054-004-43
ndc (package): 11054-004-18
ndc (package): 11054-004-36
ndc (package): 11054-004-28
ndc (package): 11054-004-25
ndc (package): 11054-004-22
ndc (package): 11054-004-40
ndc (package): 11054-004-16
ndc (package): 11054-004-13
ndc (package): 11054-004-08
ndc (package): 11054-004-05
ndc (package): 11054-004-39
ndc (package): 11054-004-06
ndc (package): 11054-004-04
ndc (product): 11054-004
ndc11 (package): 11054000427
ndc11 (package): 11054000405
ndc11 (package): 11054000421
ndc11 (package): 11054000414
ndc11 (package): 11054000442
ndc11 (package): 11054000419
ndc11 (package): 11054000439
ndc11 (package): 11054000440
ndc11 (package): 11054000420
ndc11 (package): 11054000435
ndc11 (package): 11054000422
ndc11 (package): 11054000417
ndc11 (package): 11054000443
ndc11 (package): 11054000415
ndc11 (package): 11054000424
ndc11 (package): 11054000428
ndc11 (package): 11054000413
ndc11 (package): 11054000408
ndc11 (package): 11054000401
ndc11 (package): 11054000403
ndc11 (package): 11054000432
ndc11 (package): 11054000406
ndc11 (package): 11054000431
ndc11 (package): 11054000407
ndc11 (package): 11054000411
ndc11 (package): 11054000404
ndc11 (package): 11054000430
ndc11 (package): 11054000412
ndc11 (package): 11054000410
ndc11 (package): 11054000426
ndc11 (package): 11054000436
ndc11 (package): 11054000409
ndc11 (package): 11054000418
ndc11 (package): 11054000425
ndc11 (package): 11054000429
ndc11 (package): 11054000402
ndc11 (package): 11054000437
ndc11 (package): 11054000438
ndc11 (package): 11054000434
ndc11 (package): 11054000441
ndc11 (package): 11054000423
ndc11 (package): 11054000433
ndc11 (package): 11054000416
spl id: 96b7c3dd-828b-497e-80b8-ce6caf8cb9f9
spl set id: 61d7bc2a-a22d-4640-99ee-9737d39d07fe

Reported adverse events (FAERS/openFDA)#

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