FDA.reportPublic FDA data

Helium

Manufacturer
WSM SUPPLIER LLC.
Effective date
2025-10-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:00:24

Label at a glance#

ProductHelium
Active ingredientHELIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED USP

UN1046

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. 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 preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Protect from sunlight when ambient temperature exceeds 52 C (125 F). 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 HELIUM 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.

WSM SUPPLIER LLC

3535 NW 60th Street

Miami FL 33142 (305) 455 1220

www.wsmsupplier.com heliumhelium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997972helium 99.2 % Gas for InhalationPSN3
997972helium 99.2 % Gas for InhalationSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84120-001-01Helium377 L in 1 CYLINDERGAS3773
84120-001-02Helium623 L in 1 CYLINDERGAS6233
84120-001-03Helium2143 L in 1 CYLINDERGAS21433
84120-001-04Helium2899 L in 1 CYLINDERGAS28993
84120-001-05Helium5689 L in 1 CYLINDERGAS56893
84120-001-06Helium6201 L in 1 CYLINDERGAS62013
84120-001-07Helium6338 L in 1 CYLINDERGAS63383
84120-001-08Helium6824 L in 1 CYLINDERGAS68243
84120-001-09Helium7481 L in 1 CYLINDERGAS74813
84120-001-10Helium8144 L in 1 CYLINDERGAS81443
84120-001-11Helium762 L in 1 CYLINDERGAS7623

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
84120-00184120-001-01, 84120-001-02, 84120-001-03, 84120-001-04, 84120-001-05, 84120-001-06, 84120-001-07, 84120-001-08, 84120-001-09, 84120-001-10, 84120-001-11
11054-004

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-12-02full-release2026-05-31 21:18:29

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMWSM SUPPLIER LLC.153317bb-7f55-0964-e063-6394a90a29222025-10-08Exact identifier
ndc (package): 84120-001-06
ndc (package): 84120-001-08
ndc (package): 84120-001-03
ndc (package): 84120-001-10
ndc (package): 84120-001-04
ndc (package): 84120-001-11
ndc (package): 84120-001-09
ndc (package): 84120-001-02
ndc (package): 84120-001-07
ndc (package): 84120-001-05
ndc (package): 84120-001-01
ndc (product): 84120-001
ndc11 (package): 84120000108
ndc11 (package): 84120000109
ndc11 (package): 84120000107
ndc11 (package): 84120000111
ndc11 (package): 84120000102
ndc11 (package): 84120000106
ndc11 (package): 84120000104
ndc11 (package): 84120000103
ndc11 (package): 84120000105
ndc11 (package): 84120000101
ndc11 (package): 84120000110
spl id: 40a9f139-f16f-bb51-e063-6294a90a5536
spl set id: 153317bb-7f55-0964-e063-6394a90a2922
HELIUMHELIUMAIRGAS USA, LLC61d7bc2a-a22d-4640-99ee-9737d39d07fe2025-09-03Exact identifier
ndc (product): 11054-004

Reported adverse events (FAERS/openFDA)#

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