OXYGEN
OXYGEN is an FDA drug label for the active ingredient OXYGEN manufactured by Childrens Hospital of Philadelphia administered by RESPIRATORY (INHALATION). This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260826.
- Generic name
- OXYGEN
- Manufacturer
- Childrens Hospital of Philadelphia
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- RESPIRATORY (INHALATION)
- Dosage form
- N/A
- NDC
- 43734-001
- Application
- NDA205849
- Label effective
- 20260826
About this product
OXYGEN is an FDA-registered drug product whose active ingredient is OXYGEN. It is labelled by Childrens Hospital of Philadelphia taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 43734-001, application NDA205849, label effective 20260826. It is one of 32 FDA drug label records sharing the active ingredient OXYGEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
More products with the same ingredient
OXYGENHow products containing OXYGEN compare
FDA lists 32 drug label records with OXYGEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | AMO Medical Oxygen, Inc. | 2 |
| — | — | AIRSERVE, LLC | 1 |
| — | — | Advantage Respiratory Services | 1 |
| — | — | Air Products and Chemicals, Inc. | 1 |
| — | — | Airgas USA, LLC | 1 |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0106-2024 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334. | Family Medical Supply Inc | Class II | Terminated | 20231122 |
| D-0355-2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331 | Grace Healthcare Medical, Inc | Class II | Terminated | 20210505 |
| D-1002-2019 | Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875 | Roberts Home Medical LLC | Class II | Terminated | 20190320 |
| D-1060-2017 | Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485. | AtHome Medical, Inc. | Class II | Terminated | 20170816 |
| D-1452-2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914. | Let's Talk Health, Inc. | Class II | Terminated | 20160810 |
Frequently asked questions
What is OXYGEN used for?
No indications section is present in the FDA label on file for this product. Consult the prescribing information supplied with the medicine or ask a pharmacist.
Who makes OXYGEN?
Childrens Hospital of Philadelphia is the labeler of record for OXYGEN. 32 FDA label records share the active ingredient OXYGEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does OXYGEN come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is OXYGEN prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing OXYGEN?
Yes. 32 FDA drug label records list OXYGEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has OXYGEN been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.