Helium
Helium is an FDA drug label for the active ingredient HELIUM manufactured by NexAir, LLC 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 20260522.
- Generic name
- HELIUM
- Manufacturer
- NexAir, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- RESPIRATORY (INHALATION)
- Dosage form
- N/A
- NDC
- 12213-710
- Application
- NDA209033
- Label effective
- 20260522
About this product
Helium is an FDA-registered drug product whose active ingredient is HELIUM. It is labelled by NexAir, LLC taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 12213-710, application NDA209033, label effective 20260522. 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.
Frequently asked questions
What is Helium 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 Helium?
NexAir, LLC is the labeler of record for Helium.
What form does Helium 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 Helium 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.
Has Helium been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
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.