Home NDC 10297-080-01 Heliox
Product NDC 10297-080
Requested package NDC 10297-080-01
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 3 of 5 · 82 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OXYGEN OXYGEN Johnson Drug Company, Inc 1b7bb66c-b4a2-48d9-a7df-373149da678c 2025-11-21 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Maine Oxy-Acetylene Supply Company 9a3fbd92-ccad-4d2a-af12-10aaa4855440 2025-11-20 Exact identifier application applno (NDA): 205767 application number: NDA205767 OXYGEN OXYGEN MID-SOUTH WELDING SUPPLY, INC. aae8e8ff-f579-462e-bbb7-7d710313890c 2025-11-19 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN A&B Welding Supply, LLC d8141f47-efa8-1750-e053-2995a90a32ee 2025-11-18 Exact identifier application applno (NDA): 205767 application number: NDA205767 OXYGEN OXYGEN Keen Compressed Gas Co. Inc. aefa04b2-fce7-4ec1-bcb6-6cb76c32619b 2025-11-17 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Superior Welding Supply Co 8eae8423-fe05-46e1-9db9-d18d721bffde 2025-11-14 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Baker's Gas & Welding Supplies Inc. 7f44d54e-4396-41a6-ae1f-c06efdaab1e5 2025-11-11 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR Andy-Oxy Co., Inc. 60cc80bb-8fe9-fd31-e053-2991aa0a4895 2025-10-30 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Andy-Oxy Co., Inc. 265e287a-1dca-4f5b-98db-c98be97bc811 2025-10-30 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR EUGENE WELDERS SUPPLY CO 9d0856fe-8789-4043-a938-9c368a5bf4b7 2025-10-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN EUGENE WELDERS SUPPLY CO 0f044c9f-70b1-4d19-b61f-87ce2a00b8af 2025-10-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 Carbogen CARBOGEN EUGENE WELDERS SUPPLY CO 0c69e4ce-6fbe-cd62-e063-6394a90a9e43 2025-10-29 Exact identifier application applno (NDA): 205767 application number: NDA205767 OXYGEN OXYGEN Institutional Care Pharmacy d8a10c7b-ced0-457a-b793-80116cd965de 2025-10-24 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR A-OX Welding Supply, LLC eadb1be6-f598-9124-e053-2995a90a441a 2025-10-23 Exact identifier application applno (NDA): 205767 application number: NDA205767 Heliox HELIOX A-OX Welding Supply, LLC eadb2cba-9080-77e8-e053-2a95a90afe03 2025-10-23 Exact identifier application applno (NDA): 205767 application number: NDA205767 ndc (package): 10297-080-01 ndc (product): 10297-080 ndc11 (package): 10297008001 Oxygen OXYGEN A-OX Welding Supply, LLC d810b2ee-0e09-e952-e053-2a95a90afeca 2025-10-23 Exact identifier application applno (NDA): 205767 application number: NDA205767 Air AIR AGL Welding Supply Co., Inc. 614223a6-06e2-59b3-e053-2991aa0ac66d 2025-10-22 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN AGL Inhalation Therapy Co. 52bfd8c0-d181-4eef-90f5-d8bc9d1103fb 2025-10-22 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN CRYOGENIC SOLUTIONS LLC be603b41-f90d-6130-e053-2995a90af7df 2025-10-20 Exact identifier application applno (NDA): 205767 application number: NDA205767 Oxygen OXYGEN Wesco Gas & Welding Supply, Inc. b8114d53-aa6c-4abf-998e-9db86e4b4338 2025-10-13 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