FDA.reportPublic FDA data

Helium

Manufacturer
Haun Specialty Gases, Inc.
Effective date
2025-12-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 21:53:17

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 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. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees 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 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL
Net Contents Cubic Feet: Liters:
nexAir
HAUN COMPANIES 5921 COURT STREET ROAD . SYRACUSE, NY 13206 315-463-5241 helium onehelium one

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310693helium 99 % Gas for InhalationPSN15
310693helium 99 % Gas for InhalationSCD15

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

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
14961-00514961-005-01, 14961-005-02, 14961-005-03

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
HeliumHELIUMHaun Specialty Gases, Inc.5e036b6f-95cf-4c9b-883a-12675015d4752025-12-29Exact identifier
ndc (package): 14961-005-01
ndc (package): 14961-005-02
ndc (package): 14961-005-03
ndc (product): 14961-005
ndc11 (package): 14961000502
ndc11 (package): 14961000501
ndc11 (package): 14961000503
spl id: 471b4709-87ae-bd9d-e063-6394a90a4933
spl set id: 5e036b6f-95cf-4c9b-883a-12675015d475

Reported adverse events (FAERS/openFDA)#

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