FDA.reportPublic FDA data

Helium

Manufacturer
Aero All Gas Company
Effective date
2025-10-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 22:03:16

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.

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 CONTENTS: LTRS. CU. FT.

ALL-GAS THE AERO ALL-GAS COMPANY 3150 MAIN ST. . HARTFORD, CT 06120 (860) 278-AERO (2376) 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
10014-004-10Helium623 L in 1 CYLINDERGAS62315
10014-004-11Helium3115 L in 1 CYLINDERGAS311515
10014-004-12Helium6202 L in 1 CYLINDERGAS620215
10014-004-13Helium7561 L in 1 CYLINDERGAS756115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB413
HeliumACTIVE MOIETY206GF3GB413

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
10014-00410014-004-10, 10014-004-11, 10014-004-12, 10014-004-13

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
142024-10-10full-release2026-05-31 21:14:09

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
HeliumHELIUMAero All Gas Company2e9012ae-8ff1-4858-a1e9-e2c3959b2f572025-10-28Exact identifier
ndc (package): 10014-004-13
ndc (package): 10014-004-11
ndc (package): 10014-004-12
ndc (package): 10014-004-10
ndc (product): 10014-004
ndc11 (package): 10014000410
ndc11 (package): 10014000413
ndc11 (package): 10014000411
ndc11 (package): 10014000412
spl id: 423c7fd0-edce-be76-e063-6394a90a68d7
spl set id: 2e9012ae-8ff1-4858-a1e9-e2c3959b2f57

Reported adverse events (FAERS/openFDA)#

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