FDA.reportPublic FDA data

Oxygen

Manufacturer
Founders Healthcare LLC, dba Preferred Homecare | Founders Healthcare L.L.C., dba Preferred Homecare | Founders Healthcare, L.L.C. dba Preferred Homecare
Effective date
2019-03-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:27:56

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

Principal for Oxygen Product

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RepresentativeHPLabelRepresentativeHPLabel

OXYGEN

COMPRESSED

USP

UN 1072

DANGER:

MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 °c (125 °F). Read and follow the Safety Data Sheet (SDS) before use.

CAS NO: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency

and resuscitation. For all other medical applications, Rx only.

Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen

content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN2
312172oxygen 99 % Gas for InhalationSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64346-001-012021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen
64346-001-022021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen
64346-001-032021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen
64346-001-042021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen
64346-001-052021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen
64346-001-062021-01-29C16284748780-1ba0f9c33-431a-a910-e053-dadaa90a0b85Oxygen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64346-001-01Oxygen113 L in 1 CYLINDERGAS1132
64346-001-02Oxygen164 L in 1 CYLINDERGAS1642
64346-001-03Oxygen255 L in 1 CYLINDERGAS2552
64346-001-04Oxygen425 L in 1 CYLINDERGAS4252
64346-001-05Oxygen640 L in 1 CYLINDERGAS6402
64346-001-06Oxygen680 L in 1 CYLINDERGAS6802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64346-001OXYGEN GAS [FOUNDERS HEALTHCARE LLC, DBA PREFERRED HOMECARE]2Legacy NDC, 6 package rows20190302_830afc08-bf09-e83e-e053-2991aa0a4917.zip

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
64346-00164346-001-01, 64346-001-02, 64346-001-03, 64346-001-04, 64346-001-05, 64346-001-06

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
OXYGENS88TT14065ACTIB

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
830d6e5e-c16c-36e0-e053-2a91aa0a0562830afc08-bf09-e83e-e053-2991aa0a49172019-03-01Exact identifier
spl id: 830d6e5e-c16c-36e0-e053-2a91aa0a0562
spl set id: 830afc08-bf09-e83e-e053-2991aa0a4917

Reported adverse events (FAERS/openFDA)#

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