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
IngredientStrength
OXYGEN200 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413101Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eadb2cba-9080-77e8-e053-2a95a90afe03Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10297-080-01Heliox637.13 L in 1 CYLINDERGAS637.134
10297-080-02Heliox5810.62 L in 1 CYLINDERGAS5810.624
10297-080-03Heliox7744.66 L in 1 CYLINDERGAS7744.664

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10297-080HELIOX GAS [A-OX WELDING SUPPLY CO., INC.]3Current NDC, Legacy NDC, 3 package rows20241208_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 2 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxygenOXYGENShaw Oxygen Company Inc287f2a22-daea-4d64-80a7-2f825852c6a72025-12-02Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENPURITY CYLINDER GASES INC9af33c02-3ae7-29ae-e053-2a95a90ae5472025-12-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRMinneapolis Oxygen Company4a1097df-0eda-44e8-a2cb-c89a53fc21962025-12-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENMinneapolis Oxygen Company71e087d2-b148-444d-b2d7-09a4cd3d228f2025-12-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENJames Oxygen and Supply Company39d41dbb-c44c-4ef8-9de6-a4f36648f0cb2025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENLampton Welding Supply Company, Incd9acf863-acf3-4528-bb98-f616a1cef9b42025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENT & C Flynn's Pharmacy Inc2dde8f8b-8b4f-490e-ac52-5b47f91299ce2025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENCounty Welding Supply Co.18a03db0-1ffd-4536-99a1-12e1cdd00b7c2025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRWestair Gases & Equipment, Inc.60e0a8b9-1a9c-f98c-e053-2a91aa0ab1d32025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENWestair Gases & Equipment, Inc.899be502-55ba-4795-9e75-78951d6e7aeb2025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
CarbogenCARBOGENWestair Gases & Equipment, Inc.60e0fb73-0329-5e30-e053-2a91aa0ae7792025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENBradshaw's Industrial Supply, Inc. dba Interstate Welding Supply895518e1-0912-0fb0-e053-2995a90a40c62025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENYoung Welding Supply, Incb192ed5e-f641-7b31-e053-2a95a90a0dde2025-11-26Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRDale Oxygen And Acetylene Service, Inc4b45f833-b33c-4518-a755-86fa887953a72025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENDale Oxygen And Acetylene Service, Inc43d1f68d-874b-4cbc-94ff-fd498cc9f2c12025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
Oxygen Carbon DioxideOXYGEN CARBON DIOXIDEMEDICAL-TECHNICAL GASES, INC.1d72e61f-f9b4-3d01-e063-6394a90ab1f92025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENMEDICAL-TECHNICAL GASES, INC.eb3ce21e-e605-6260-e053-2a95a90a75e12025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
oxygenOXYGENA & E Mill & Welding Supply Companyfeb9f3f3-f910-4936-8cde-60e1b8cf76bc2025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENS. J. Smith Co., Inc.89544705-5d9d-4595-8870-fa46c9c14af22025-11-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
oxygenOXYGENOz Arc/gas Equipment & Supply, Inc.78b4bb26-f66a-4f5a-801b-d42637ff294b2025-11-21Exact identifier
application applno (NDA): 205767
application number: NDA205767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413101oxygen 20 % Gas for InhalationPSNeadb2cba-9080-77e8-e053-2a95a90afe034
413101oxygen 20 % Gas for InhalationSCDeadb2cba-9080-77e8-e053-2a95a90afe034
413101nitrogen (inactive) 80 % / oxygen 20 % Gas for InhalationSYeadb2cba-9080-77e8-e053-2a95a90afe034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10297-080-0110297008001637.13 L in 1 CYLINDER (10297-080-01) 637.13 l2018-06-010000-00-00NoNoCurrent