FDA.reportPublic FDA data

Oxygen

Manufacturer
Andy-Oxy Co., Inc.
Effective date
2025-10-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-05-31 22:03:14

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

PRODUCED BY AIR LIQUEFACTION

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required. 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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. 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 preventative 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 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.

ANDY OXY CO., INC

27 HERITAGE DR. ASHEVILLE, NC 28806

(828) 258-0271

NO SMOKING

NO VAPING oxygen 2025oxygen 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312173oxygen 99.5 % Gas for InhalationPSN16
312173oxygen 99.5 % Gas for InhalationSCD16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50063-001-01Oxygen368 L in 1 CYLINDERGAS36816
50063-001-02Oxygen623 L in 1 CYLINDERGAS62316
50063-001-03Oxygen99 L in 1 CYLINDERGAS9916
50063-001-04Oxygen156 L in 1 CYLINDERGAS15616
50063-001-05Oxygen235 L in 1 CYLINDERGAS23516
50063-001-06Oxygen3455 L in 1 CYLINDERGAS345516
50063-001-07Oxygen1699 L in 1 CYLINDERGAS169916
50063-001-08Oxygen2379 L in 1 CYLINDERGAS237916
50063-001-09Oxygen4248 L in 1 CYLINDERGAS424816
50063-001-10Oxygen6909 L in 1 CYLINDERGAS690916
50063-001-11Oxygen9345 L in 1 CYLINDERGAS934516
50063-001-12Oxygen137054 L in 1 DEWARGAS13705416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OxygenACTIVE INGREDIENTS88TT140655
OxygenACTIVE MOIETYS88TT140655

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
50063-00150063-001-01, 50063-001-02, 50063-001-03, 50063-001-04, 50063-001-05, 50063-001-06, 50063-001-07, 50063-001-08, 50063-001-09, 50063-001-10, 50063-001-11, 50063-001-12

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152024-10-10full-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
OxygenOXYGENAndy-Oxy Co., Inc.265e287a-1dca-4f5b-98db-c98be97bc8112025-10-30Exact identifier
ndc (package): 50063-001-01
ndc (package): 50063-001-05
ndc (package): 50063-001-08
ndc (package): 50063-001-04
ndc (package): 50063-001-07
ndc (package): 50063-001-10
ndc (package): 50063-001-12
ndc (package): 50063-001-11
ndc (package): 50063-001-09
ndc (package): 50063-001-03
ndc (package): 50063-001-02
ndc (package): 50063-001-06
ndc (product): 50063-001
ndc11 (package): 50063000105
ndc11 (package): 50063000106
ndc11 (package): 50063000103
ndc11 (package): 50063000107
ndc11 (package): 50063000109
ndc11 (package): 50063000102
ndc11 (package): 50063000110
ndc11 (package): 50063000111
ndc11 (package): 50063000108
ndc11 (package): 50063000101
ndc11 (package): 50063000104
ndc11 (package): 50063000112
spl id: 426518bd-9cc4-0d24-e063-6294a90a3649
spl set id: 265e287a-1dca-4f5b-98db-c98be97bc811

Reported adverse events (FAERS/openFDA)#

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