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Prescription medicine

Oxygen

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

Does Oxygen have a boxed warning?
No. None of the 240 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Oxygen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Oxygen been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started October 10, 2013 (Class II). A recall usually concerns specific lots, not every product.
Who makes Oxygen?
205 companies list prescription products of Oxygen in the FDA NDC Directory, including Matheson Tri-Gas, Inc., Roberts Oxygen Company, Inc. and General Air Service & Supply Co.

What Oxygen is used for

We did not find an “Indications and Usage” section in the FDA labels for this medicine. See the label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 240 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsGas · Liquid
RouteRespiratory (inhalation) · Nasal · Cutaneous
Prescription products295 in the FDA NDC Directory
Brand namesMedical Air, Oxygen Compressed, Air Compressed, Air, Compressed, Medical Oxygen Compressed, Oxygen Refrigerated Liquid

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA205712
OXYGEN, USP
Air Liquid Industrial Us LPJune 16, 2013 —
NDA205737
OXYGEN, USP
Air Liquide Large Industries Us LPJune 23, 2013 —
NDA205765
MEDICAL AIR, USP
Linde North America IncJuly 5, 2013 —
NDA205767
OXYGEN, USP
Linde North America IncJuly 5, 2013 —
NDA205817
OXYGEN, USP
Linde North America IncJuly 5, 2013 —
NDA205818
OXYGEN, USP
Linde Gas Puerto Rico IncJuly 5, 2013 —
NDA205820
OXYGEN, USP
Norco IncJuly 14, 2013 —
NDA205827
OXYGEN, USP
Air Liquide America LPJuly 13, 2013 —
NDA205840
OXYGEN, USP
Airgas Merchants Gases LLCJuly 16, 2013 —
NDA205845
MEDICAL AIR, USP
Airgas USA LLCJuly 20, 2013 —
NDA205849
OXYGEN, USP
Praxair IncJuly 21, 2013 —
NDA205862
OXYGEN, USP
Aspen AirJuly 23, 2013 —
NDA205865
OXYGEN, USP
Air Products and Chemicals IncJuly 23, 2013 —
NDA205889
OXYGEN, USP
Matheson Tri-Gas IncAugust 2, 2013 —
NDA205986
OXYGEN, USP
Praxair Canada IncAugust 27, 2013 —
NDA205992
MEDICAL AIR, USP
United States Welding IncAugust 31, 2013 —
NDA206023
OXYGEN, USP
Airgas USA LLCSeptember 7, 2013 —
NDA211270
MEDICAL AIR, USP
Linde Gas Puerto Rico IncDecember 17, 2017 —
NDA211739
OXYGEN, USP
Cristal Asu LLCSeptember 10, 2018 —
NDA212314
OXYGEN, USP
Universal Industrial Gases, IncAugust 24, 2018 —
NDA217500
OXYGEN, USP
Absolute Air, LLCJune 10, 2022 —

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. October 10, 2013 · Class II · Terminated · D-386-2014

    Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

    Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009 — Airgas Medical Services

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)309002, 311998, 312172, 312173, 312174, 312175, 347048, 347093, 347123, 347131 … (+10)
SPL set ID of the quoted labeld7c32a52-b342-2efb-e053-2a95a90adfc5
FDA labels (SPL)240
FDA applicationsNDA205712, NDA205737, NDA205765, NDA205767, NDA205817, NDA205818, NDA205820, NDA205827, NDA205840, NDA205845, NDA205849, NDA205862, NDA205865, NDA205889, NDA205986, NDA205992, NDA206023, NDA211270, NDA211739, NDA212314, NDA217500
Active ingredients (FDA)OXYGEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Medical Air, Keen Compressed Gas Co. Inc., effective November 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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