FDA.reportPublic FDA data

Helium

Manufacturer
GT Industries Inc
Effective date
2010-05-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:09:14

Label at a glance#

ProductHelium
Active ingredientHelium
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED U.S.P.
NON-FLAMMABLE GAS 2           
WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. 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. Use in accordance with the MSDS and the precautions recommended by the supplier. DO NOT REMOVE THIS PRODUCT LABEL. GT INDUSTRIES 800 RAVIA RD. SULPHUR, LA 70663 PH# 318-583-9278 EMERGENCY PHONE 1-800-641-4357heliumhelium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310693helium 99 % Gas for InhalationPSN1
310693helium 99 % Gas for InhalationSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61095-300-012019-10-21C16284748780-1956f9ecf-d014-621f-e053-dbdaa90a74adhelium
61095-300-022019-10-21C16284748780-1956f9ecf-d014-621f-e053-dbdaa90a74adhelium
61095-300-032019-10-21C16284748780-1956f9ecf-d014-621f-e053-dbdaa90a74adhelium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61095-300-01Helium622 L in 1 CYLINDERGAS6221
61095-300-02Helium368 L in 1 CYLINDERGAS3681
61095-300-03Helium651 L in 1 CYLINDERGAS6511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61095-300HELIUM GAS [GT INDUSTRIES INC]1Legacy NDC, 3 package rows20100719_8d8799df-0ccd-44f4-8724-5dc0e33e13d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB411
HeliumACTIVE MOIETY206GF3GB411

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
61095-30061095-300-01, 61095-300-02, 61095-300-03

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

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
20b3af9a-5d4c-4bcc-bfdc-691e2f4755108d8799df-0ccd-44f4-8724-5dc0e33e13d72010-05-25Exact identifier
spl id: 20b3af9a-5d4c-4bcc-bfdc-691e2f475510
spl set id: 8d8799df-0ccd-44f4-8724-5dc0e33e13d7

Reported adverse events (FAERS/openFDA)#

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