Home NDC 10297-080 Heliox
Product NDC 10297-080
11-digit product format 102970080
Labeler code 10297
Product ID 10297-080_41d955de-b739-1d45-e063-6394a90a1bc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heliox
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler A-OX Welding Supply, LLC
Application NDA205767
Marketing category NDA
Marketing start 2018-06-01
Substance OXYGEN
Active strength 200 mL/L
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Heliox
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYGEN 200 mL/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S88TT14065 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 413101 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10297-080-01 Heliox 637.13 L in 1 CYLINDER GAS 637.13 4 10297-080-02 Heliox 5810.62 L in 1 CYLINDER GAS 5810.62 4 10297-080-03 Heliox 7744.66 L in 1 CYLINDER GAS 7744.66 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10297-080 HELIOX GAS [A-OX WELDING SUPPLY CO., INC.] 3 Current NDC, Legacy NDC, 3 package rows 20241208_eadb2cba-9080-77e8-e053-2a95a90afe03.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 1 of 5 · 82 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxygen OXYGEN Atlas Welding Supply Company, Inc. 85c52db3-ce42-4306-9bf3-451b56bbba82 2026-07-15 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR Maine Oxy-Acetylene Supply Company 03140c87-86d2-4753-abd1-737e50c9041e 2026-06-18 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Gulf Coast Gas & Equipment, LLC 374cdd84-3d25-28b3-e063-6394a90a9f24 2026-05-28 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Messer LLC 0de4fe56-80c8-06be-da02-b145e0a5dbf2 2026-04-13 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Machine & Welding Supply Company dba Arc3 Gases South 08936fbe-b98b-4a97-a99b-3e06caa15aaf 2026-03-04 Exact identifier application applno (NDA): 205767 application number: NDA205767 OXYGEN OXYGEN CEE-KAY SUPPLY, INC. 7a4aa7ab-08a4-4e93-90d7-5329b0e1a61b 2026-02-25 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen Helium Mixture 30/70 OXYGEN HELIUM MIXTURE 30/70 AGL Inhalation Therapy Co. 3c799e75-d974-4f9d-bd47-0ffbd05b8b98 2026-01-01 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen Helium Mixture 20/80 OXYGEN HELIUM MIXTURE 20/80 AGL Inhalation Therapy Co. e5f7f27b-5c9d-47f3-8312-641cb8b3ffd1 2026-01-01 Exact identifier application applno (NDA): 205767 application number: NDA205767 Carbon Dioxide Oxygen Mixture 5/95 CARBON DIOXIDE OXYGEN MIXTURE 5/95 AGL Inhalation Therapy Co. a5a3db93-de47-4685-9c20-dbf0ff30047a 2026-01-01 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Haun Welding Supply, Inc. 97ccccd8-4da5-f521-e053-2a95a90a0faf 2025-12-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Haun Specialty Gases, Inc. 97cc950c-ea97-c25b-e053-2995a90a16c6 2025-12-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR Haun Specialty Gases, Inc. 7e4b94e3-b4fb-4968-bfce-9ad508eea78b 2025-12-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR - INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. d85840d6-c7ea-4a52-81a0-feaf43c2a0e5 2025-12-19 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN WEST PENN LACO, INC. bd2023e7-da7d-7777-e053-2995a90aa64f 2025-12-09 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Gas and Supply Carolinas, LLC 05a73ef4-f9ba-f4fc-e063-6294a90a8321 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN - INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. 469e1310-0fa3-4481-a1be-cd8889c4abc1 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Jayco Industrial Supply Inc 8d86f28c-3bab-4728-ad92-e8e9f779f386 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Southern Gas and Supply LLC 8a9b0cb5-3236-4de4-a97d-eb247c6c7c68 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Southern Gas and Supply of Mississippi, Inc. 1951ddf8-0a94-4678-8ade-198fe356703a 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN SOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply 9af03e06-8add-2b72-e053-2995a90ab829 2025-12-08 Exact identifier application applno (NDA): 205767 application number: NDA205767
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10297-080-01 10297008001 637.13 L in 1 CYLINDER (10297-080-01) 637.13 l 2018-06-01 0000-00-00 No No Current 10297-080-02 10297008002 5810.62 L in 1 CYLINDER (10297-080-02) 5810.62 l 2018-06-01 0000-00-00 No No Current 10297-080-03 10297008003 7744.66 L in 1 CYLINDER (10297-080-03) 7744.66 l 2018-06-01 0000-00-00 No No Current