FDA.reportPublic FDA data

Helium Label

Manufacturer
NexAir, LLC
Effective date
2026-05-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
85
Source
full-release
Hydrated at
2026-05-31 22:21:15

Label at a glance#

ProductHelium
Active ingredientHELIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UN1046

HELIUM, COMPRESSED USP

DO NOT REMOVE THIS LABEL

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. Do not open valve until connected to equipment prepared for use. Close valve after each use and when empty. Do not inhale for recreational use. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AIR: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. 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.

Rx ONLY

IN CASE OF EMERGENCY: CALL 1-888-639-2474

CAS: 7440-59-7

nexAir

Distributed by nexAir, LLC, 1350 Concourse Ave., Suite 103, Memphis, TN 38104 helium 2025helium 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
347675helium 99.9 % Gas for InhalationPSN85
347675helium 99.9 % Gas for InhalationSCD85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-710-12Helium6145 L in 1 CYLINDERGAS614585
12213-710-13Helium408 L in 1 CYLINDERGAS40885
12213-710-20Helium6201 L in 1 CYLINDERGAS620185
12213-710-21Helium8240 L in 1 CYLINDERGAS824085
12213-710-22Helium1019 L in 1 CYLINDERGAS101985
12213-710-40Helium425 L in 1 CYLINDERGAS42585
12213-710-50Helium2067 L in 1 CYLINDERGAS206785
12213-710-58Helium586 L in 1 CYLINDERGAS58685
12213-710-60Helium113 L in 1 CYLINDERGAS11385

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB417
HeliumACTIVE MOIETY206GF3GB417

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
12213-71012213-710-60, 12213-710-13, 12213-710-40, 12213-710-58, 12213-710-50, 12213-710-12, 12213-710-20, 12213-710-21, 12213-710-22

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
222026-01-13monthly-update2026-06-03 17:55:17

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
HeliumHELIUMNexAir, LLCcb33fc07-e122-4f66-aa43-b659ee1501502026-05-22Exact identifier
ndc (package): 12213-710-40
ndc (package): 12213-710-58
ndc (package): 12213-710-20
ndc (package): 12213-710-21
ndc (package): 12213-710-13
ndc (package): 12213-710-22
ndc (package): 12213-710-12
ndc (package): 12213-710-60
ndc (package): 12213-710-50
ndc (product): 12213-710
ndc11 (package): 12213071022
ndc11 (package): 12213071013
ndc11 (package): 12213071050
ndc11 (package): 12213071060
ndc11 (package): 12213071021
ndc11 (package): 12213071012
ndc11 (package): 12213071058
ndc11 (package): 12213071020
ndc11 (package): 12213071040
spl id: 4279510c-94a2-86a7-e063-6394a90ab2e6
spl set id: cb33fc07-e122-4f66-aa43-b659ee150150

Reported adverse events (FAERS/openFDA)#

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