FDA.reportPublic FDA data

Oxygen

Manufacturer
Indian River Oxygen, Inc.
Effective date
2025-11-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:47:33

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure2 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 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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.

INDIAN RIVER OXYGEN, INC.

650 ANGLE ROAD

FORT PIERCE, FL 34947 772-461-7745

NO SMOKING

NO VAPING oxygen 2025oxygen 2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

Produced by Air Liquefaction.

CONTENTS: LTRS. CU. FT.

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 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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.

NO SMOKING

NO VAPING

INDIAN RIVER OXYGEN, INC.

650 ANGLE ROAD

FORT PIERCE, FL 34947 772-461-7745 oxygen two 2025oxygen two 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
348381oxygen 99.8 % Gas for InhalationPSN8
348381oxygen 99.8 % Gas for InhalationSCD8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60980-002-01Oxygen2265 L in 1 CYLINDERGAS22658
60980-002-02Oxygen3454 L in 1 CYLINDERGAS34548
60980-002-03Oxygen6909 L in 1 CYLINDERGAS69098
60980-002-04Oxygen9344 L in 1 CYLINDERGAS93448
60980-002-05Oxygen5097 L in 1 CYLINDERGAS50978
60980-002-06Oxygen240 L in 1 CYLINDERGAS2408
60980-002-07Oxygen680 L in 1 CYLINDERGAS6808
60980-002-08Oxygen164 L in 1 CYLINDERGAS1648
60980-002-09Oxygen255 L in 1 CYLINDERGAS2558
60980-002-10Oxygen425 L in 1 CYLINDERGAS4258
60980-002-11Oxygen180 L in 1 DEWARGAS1808

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
60980-00260980-002-01, 60980-002-02, 60980-002-03, 60980-002-04, 60980-002-05, 60980-002-06, 60980-002-07, 60980-002-08, 60980-002-09, 60980-002-10, 60980-002-11

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

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
OxygenOXYGENIndian River Oxygen, Inc.9aef32b3-6174-8d3e-e053-2995a90a8bf82025-11-26Exact identifier
ndc (package): 60980-002-01
ndc (package): 60980-002-03
ndc (package): 60980-002-02
ndc (package): 60980-002-08
ndc (package): 60980-002-09
ndc (package): 60980-002-05
ndc (package): 60980-002-07
ndc (package): 60980-002-11
ndc (package): 60980-002-04
ndc (package): 60980-002-10
ndc (package): 60980-002-06
ndc (product): 60980-002
ndc11 (package): 60980000211
ndc11 (package): 60980000207
ndc11 (package): 60980000209
ndc11 (package): 60980000202
ndc11 (package): 60980000205
ndc11 (package): 60980000206
ndc11 (package): 60980000201
ndc11 (package): 60980000210
ndc11 (package): 60980000204
ndc11 (package): 60980000203
ndc11 (package): 60980000208
spl id: 44880f62-0a4a-1844-e063-6294a90a4131
spl set id: 9aef32b3-6174-8d3e-e053-2995a90a8bf8

Reported adverse events (FAERS/openFDA)#

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