FDA.reportPublic FDA data

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
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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENNoble Gas Solutions, Inc.13ce9fe8-ca43-4564-87b2-f8e97570dcfd2024-10-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENADF Welding & Medical, Inc.01efe36d-5281-4ede-bc30-9a1727a86a832024-10-02Exact 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
10297-080-02102970080025810.62 L in 1 CYLINDER (10297-080-02) 5810.62 l2018-06-010000-00-00NoNoCurrent
10297-080-03102970080037744.66 L in 1 CYLINDER (10297-080-03) 7744.66 l2018-06-010000-00-00NoNoCurrent