FDA.reportPublic FDA data

Oxygen

Manufacturer
S. J. Smith Co., Inc.
Effective date
2025-11-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 21:47:15

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; 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.

SJ SMITH

3707 WEST RIVER DR DAVENPORT, IA 52802

563-324-5237

NO SMOKING

NO VAPING

CONTENTS (LITERS)

9401

7051

3511

643

387

234

141 oxygen 2025oxygen 2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REFRIGERATED LIQUID

OXYGEN, REFRIGERATED LIQUID USP

UN1073

NO SMOKING

NO VAPING

CONTENTS: 145692 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.

Produced by Air Liquefaction.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH OXIDIZING REFRIGERATED LIQUIDS MAY EXPLODE ON IGNITION OR IMPACT. Obtain, read and follow all safety instructions before use. 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. Wear cold insulating gloves and either face shield or eye protection. 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. Always keep container in upright position. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ON SKIN: Immediately thaw frosted parts with lukewarm water. Do not rub affected area. Get medical help.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

SJ SMITH

3707 WEST RIVER DR DAVENPORT, IA 52802

563-324-5237 refrig oxygen 2025refrig oxygen 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
348831oxygen 99.2 % Gas for InhalationPSN17
348831oxygen 99.2 % Gas for InhalationSCD17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11043-001-01Oxygen154326 L in 1 DEWARGAS15432617
11043-001-02Oxygen7107 L in 1 CYLINDERGAS710717
11043-001-03Oxygen3539 L in 1 CYLINDERGAS353917
11043-001-04Oxygen651 L in 1 CYLINDERGAS65117
11043-001-05Oxygen396 L in 1 CYLINDERGAS39617
11043-001-06Oxygen141 L in 1 CYLINDERGAS14117
11043-001-07Oxygen127425 L in 1 DEWARGAS12742517
11043-001-08Oxygen145692 L in 1 DEWARGAS14569217
11043-001-09Oxygen9340 L in 1 CYLINDERGAS934017
11043-001-10Oxygen255 L in 1 CYLINDERGAS25517
11043-001-11Oxygen30 L in 1 CYLINDERGAS3017
11043-001-12Oxygen41 L in 1 CYLINDERGAS4117
11043-001-13Oxygen154326.81 L in 1 CANGAS154326.8117
11043-001-14Oxygen150 L in 1 CYLINDERGAS15017
11043-001-15Oxygen3831 L in 1 CYLINDERGAS383117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT140652
OXYGENACTIVE MOIETYS88TT140652

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
11043-00111043-001-01, 11043-001-02, 11043-001-03, 11043-001-04, 11043-001-05, 11043-001-06, 11043-001-07, 11043-001-08, 11043-001-09, 11043-001-10, 11043-001-11, 11043-001-12, 11043-001-13, 11043-001-14, 11043-001-15

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
OxygenOXYGENS. J. Smith Co., Inc.89544705-5d9d-4595-8870-fa46c9c14af22025-11-25Exact identifier
ndc (package): 11043-001-08
ndc (package): 11043-001-06
ndc (package): 11043-001-02
ndc (package): 11043-001-13
ndc (package): 11043-001-09
ndc (package): 11043-001-11
ndc (package): 11043-001-04
ndc (package): 11043-001-01
ndc (package): 11043-001-05
ndc (package): 11043-001-14
ndc (package): 11043-001-03
ndc (package): 11043-001-07
ndc (package): 11043-001-10
ndc (package): 11043-001-15
ndc (package): 11043-001-12
ndc (product): 11043-001
ndc11 (package): 11043000101
ndc11 (package): 11043000103
ndc11 (package): 11043000106
ndc11 (package): 11043000105
ndc11 (package): 11043000107
ndc11 (package): 11043000108
ndc11 (package): 11043000104
ndc11 (package): 11043000111
ndc11 (package): 11043000109
ndc11 (package): 11043000102
ndc11 (package): 11043000113
ndc11 (package): 11043000115
ndc11 (package): 11043000114
ndc11 (package): 11043000112
ndc11 (package): 11043000110
spl id: 4476ac0d-cd1f-74ca-e063-6394a90a5713
spl set id: 89544705-5d9d-4595-8870-fa46c9c14af2

Reported adverse events (FAERS/openFDA)#

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