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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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 firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

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

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 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

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