FDA.reportPublic FDA data

Helium/Oxygen Mix

Product NDC
12213-801
11-digit product format
122130801
Labeler code
12213
Product ID
12213-801_4279490a-a12b-05d4-e063-6394a90afa67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium/Oxygen Mix
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NEXAIR, LLC
Application
NDA205849
Marketing category
NDA
Marketing start
1996-06-01
Substance
OXYGEN
Active strength
200 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12213-80112213-801-28DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENEmpresas De Soldaduras6f57cec9-9132-4ba4-a033-538c3a39ff9c2026-07-27Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENAdvantage Respiratory Services972755ee-f07f-485c-ba34-8e601f4685122026-06-18Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENNexAir, LLCaba44023-4919-4711-992c-aa59dfe366a92026-05-21Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENLinde Gas & Equipment Inc.a5bcde43-c0e8-4db8-bd4f-6f3af00b9b172026-04-20Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENAlbright Welding Supply Co., Inc.80c05bc5-4918-4998-b5eb-4ca8b59bf7162026-01-08Exact identifier
application applno (NDA): 205849
application number: NDA205849
NitrogenNITROGENLinde Puerto Rico B.V.4e5df6ce-06ef-498f-b064-b2b6e15219512025-12-31Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENLinde Inc.58ca942f-16ba-49fe-a1aa-d62dddeaca6b2025-12-30Exact identifier
application applno (NDA): 205849
application number: NDA205849
Carbon Dioxide Oxygen MixCARBON DIOXIDE OXYGEN MIXLinde Gas & Equipment Inc.b5f6d869-6875-4c82-9311-98a148790c0b2025-12-19Exact identifier
application applno (NDA): 205849
application number: NDA205849
AirAIRGeneral Air Service & Supply Co60df0f08-6622-6cb5-e053-2a91aa0a77602025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Carbon Dioxide Oxygen MixtureCARBON DIOXIDE OXYGEN MIXTUREGeneral Air Service & Supply Co620d348d-75e6-3d1a-e053-2991aa0a855f2025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen Nitrogen MixtureOXYGEN NITROGEN MIXTUREGeneral Air Service & Supply Co.c7f7500c-b521-4d93-a567-898ca4f778f42025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Helium/Oxygen Mixture 80/20HELIUM/OXYGEN MIXTURE 80/20General Air Service & Supply Co.60df34a1-e3fa-6959-e053-2a91aa0a47602025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Helium/Oxygen Mixture 70/30HELIUM/OXYGEN MIXTURE 70/30General Air Service & Supply Co620d5fe1-f7f1-8de7-e053-2a91aa0a86642025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENGeneral Air Service & Supply Co60399781-bcf4-4675-afb9-6d8b2670efa02025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENOxarc, LLC23eabc18-eded-466a-9524-6d0f0e4831572025-11-25Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENGeneral Cryogenic Technologies LLCc071ca0b-a330-4579-a1b8-d4b4c5824a092025-11-21Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENT.W. Smith Corp.35835f7d-2f1e-0e11-e063-6294a90ad5262025-11-19Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen-Helium MixtureOXYGEN-HELIUM MIXTURERoberts Oxygen Company, Inc.2c3b2f64-cf21-d203-e063-6394a90a52de2025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen-Nitrogen MixtureOXYGEN-NITROGEN MIXTURERoberts Oxygen Company, Inc.2bed8d10-0a93-3c8a-e063-6294a90a91002025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen-Helium MixtureOXYGEN-HELIUM MIXTURERoberts Oxygen Company, Inc.2c3b1e14-622f-a6d2-e063-6394a90a0e6d2025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849

Additional Listing Data#

Finished product
Yes
Brand name base
Helium/Oxygen Mix
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
60dd4f4b-7132-385e-e053-2a91aa0ad5d6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-801-01Helium/Oxygen Mix5987.5 L in 1 CYLINDERGAS5987.510
12213-801-02Helium/Oxygen Mix5774 L in 1 CYLINDERGAS577410
12213-801-03Helium/Oxygen Mix6201 L in 1 CYLINDERGAS620110
12213-801-04Helium/Oxygen Mix586 L in 1 CYLINDERGAS58610
12213-801-05Helium/Oxygen Mix5856 L in 1 CYLINDERGAS585610
12213-801-06Helium/Oxygen Mix5938 L in 1 CYLINDERGAS593810
12213-801-12Helium/Oxygen Mix5663 L in 1 CYLINDERGAS566310
12213-801-13Helium/Oxygen Mix382 L in 1 CYLINDERGAS38210
12213-801-28Helium/Oxygen Mix561 L in 1 CYLINDERGAS56110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-801HELIUM/OXYGEN MIX GAS [NEXAIR, LLC]9Current NDC, Legacy NDC, 9 package rows20241114_60dd4f4b-7132-385e-e053-2a91aa0ad5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413101oxygen 20 % Gas for InhalationPSN60dd4f4b-7132-385e-e053-2a91aa0ad5d610
413101oxygen 20 % Gas for InhalationSCD60dd4f4b-7132-385e-e053-2a91aa0ad5d610
413101nitrogen (inactive) 80 % / oxygen 20 % Gas for InhalationSY60dd4f4b-7132-385e-e053-2a91aa0ad5d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-801-01122130801015987.5 L in 1 CYLINDER (12213-801-01) 5987.5 l1996-06-010000-00-00NoNoCurrent
12213-801-02122130801025774 L in 1 CYLINDER (12213-801-02) 5774 l1996-06-010000-00-00NoNoCurrent
12213-801-03122130801036201 L in 1 CYLINDER (12213-801-03) 6201 l1996-06-010000-00-00NoNoCurrent
12213-801-0412213080104586 L in 1 CYLINDER (12213-801-04) 586 l1996-06-010000-00-00NoNoCurrent
12213-801-05122130801055856 L in 1 CYLINDER (12213-801-05) 5856 l1996-06-010000-00-00NoNoCurrent
12213-801-06122130801065938 L in 1 CYLINDER (12213-801-06) 5938 l1996-06-010000-00-00NoNoCurrent
12213-801-12122130801125663 L in 1 CYLINDER (12213-801-12) 5663 l1996-06-010000-00-00NoNoCurrent
12213-801-1312213080113382 L in 1 CYLINDER (12213-801-13) 382 l1996-06-010000-00-00NoNoCurrent
12213-801-2812213080128561 L in 1 CYLINDER (12213-801-28) 561 l1996-06-010000-00-00NoNoCurrent