FDA.reportPublic FDA data

Heliox

Product NDC
54776-006
11-digit product format
547760006
Labeler code
54776
Product ID
54776-006_eb40a93c-f782-317c-e053-2995a90ae19e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heliox
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Spec Connection International Inc
Application
NDA205889
Marketing category
NDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
300 mL/L
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54776-006DDiscontinued by firm2026-10-05
excluded packagepackage54776-00654776-006-01DDiscontinued by firm2026-10-05
excluded packagepackage54776-00654776-006-02DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct54776-006DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54776-00654776-006-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54776-00654776-006-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54776-006HELIOX GAS [SPEC CONNECTION INTERNATIONAL INC]8Legacy NDC20241121_614182b5-5aa5-9efd-e053-2991aa0a7578.zip

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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxygen/Nitrogen 12/88OXYGEN/NITROGEN 12/88MATHESON TRI-GAS, INC.f525d24f-5008-93aa-e053-2a95a90acbcb2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 30/70OXYGEN/NITROGEN 30/70MATHESON TRI-GAS, INC.f5262a2b-6bd4-4615-e053-2995a90aaf582025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 52/48OXYGEN/NITROGEN 52/48MATHESON TRI-GAS, INC.f5266e8f-60fb-cd73-e053-2995a90a021d2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 50/50OXYGEN/NITROGEN 50/50MATHESON TRI-GAS, INC.f5266223-b40d-6c48-e053-2995a90a39122025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 40/60OXYGEN/NITROGEN 40/60MATHESON TRI-GAS, INC.f52647f0-aba5-501d-e053-2995a90a94642025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 40/60OXYGEN/HELIUM 40/60MATHESON TRI-GAS, INC.10bcc7cd-ce72-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 5/95OXYGEN/NITROGEN 5/95MATHESON TRI-GAS, INC.f526545f-712a-6c4a-e053-2995a90abab02025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 75/25OXYGEN/NITROGEN 75/25MATHESON TRI-GAS, INC.f526707a-f4cd-37af-e053-2995a90a85242025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide/Oxygen 5/95CARBON DIOXIDE/OXYGEN 5/95MATHESON TRI-GAS, INC.10bcb4be-21f8-0683-e063-6294a90a50362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 20/80OXYGEN/HELIUM 20/80MATHESON TRI-GAS, INC.10bcb79f-9346-5b4c-e063-6394a90a0c262025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide OxygenCARBON DIOXIDE OXYGENMATHESON TRI-GAS, INC.10bca54e-777c-03f5-e063-6294a90aed2c2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 50/50OXYGEN/HELIUM 50/50MATHESON TRI-GAS, INC.10bcc7cd-ce75-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 21/79OXYGEN/NITROGEN 21/79MATHESON TRI-GAS, INC.f5255f85-970d-43c7-e053-2995a90ac4362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 30/70OXYGEN/HELIUM 30/70MATHESON TRI-GAS, INC.10bcca0f-1f2b-1163-e063-6294a90af1862025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENVolunteer Welding Supply Inc2e9baf05-c0d3-4361-82c3-e18a5bca8cd12025-11-26Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENIsland Supply Welding Co Inc9a84e50c-504a-4e7d-8595-ebce7d78d1272025-11-21Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC82316046-e3e0-7b8d-e053-2a91aa0aa69b2025-11-18Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRGeneral Distributing Company60cf6286-12d5-24a1-e053-2991aa0a9d742025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENGeneral Distributing Co.ffa52347-b223-4ff8-acaa-1462f2dfb5282025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENModern Supply Company, Inc.4a1cddbc-27f1-4a7c-b2de-5158bddf3efd2025-10-30Exact identifier
application applno (NDA): 205889
application number: NDA205889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54776-006-0154776000601707 L in 1 CYLINDER (54776-006-01) 707 l2013-01-010000-00-00NoNoCurrent
54776-006-02547760006025663 L in 1 CYLINDER (54776-006-02) 5663 l2013-01-010000-00-00NoNoCurrent