Oxygen

Manufacturer
Smith's Home Medical Equipment, Inc.
Effective date
2025-10-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 22:00:10

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

Principal for Oxygen Product

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative HP LabelRepresentative HP Label

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

RepresentativeLotStickerRepresentativeLotSticker

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN13
312172oxygen 99 % Gas for InhalationSCD13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35420-123-012023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032023-02-17C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032023-01-30C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032021-06-14C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-012021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-022021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP
35420-123-032021-01-29C16284748780-1ba0f9c33-5414-a910-e053-dadaa90a0b85Oxygen, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35420-123-01Oxygen164 L in 1 CYLINDERGAS16413
35420-123-02Oxygen425 L in 1 CYLINDERGAS42513
35420-123-03Oxygen680 L in 1 CYLINDERGAS68013

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
35420-12335420-123-01, 35420-123-02, 35420-123-03

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
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122024-10-03full-release2026-05-31 21:13:29

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
OxygenOXYGENSmith's Home Medical Equipment, Inc.7b0b3b9f-4c2d-5bb2-e053-2991aa0aca0b2025-10-06Exact identifier
ndc (package): 35420-123-02
ndc (package): 35420-123-01
ndc (package): 35420-123-03
ndc (product): 35420-123
ndc11 (package): 35420012302
ndc11 (package): 35420012303
ndc11 (package): 35420012301
spl id: 407fe4e3-4f60-8ba8-e063-6394a90a80d1
spl set id: 7b0b3b9f-4c2d-5bb2-e053-2991aa0aca0b

Reported adverse events (FAERS/openFDA)#

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