Home NDC 12213-801 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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Helium/Oxygen Mix
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12213-801 HELIUM/OXYGEN MIX GAS [NEXAIR, LLC] 9 Current NDC, Legacy NDC, 9 package rows 20241114_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 3 of 4 · 77 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE-OXYGEN MIXTURE Roberts Oxygen Company, Inc. 2beb4f04-572d-4291-e063-6294a90a173a 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE-OXYGEN MIXTURE Roberts Oxygen Company, Inc. 2bead32e-888c-0c6a-e063-6294a90a3a61 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Air Mixture CARBON DIOXIDE-AIR MIXTURE Roberts Oxygen Company, Inc. 2be98fb6-ba91-f46c-e063-6294a90a28cf 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Oxygen OXYGEN Roberts Oxygen Company, Inc. af2c897d-7337-4467-b968-4a7e4794c5cc 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE-OXYGEN MIXTURE Roberts Oxygen Company, Inc. c9fee13d-f4d5-445b-839a-d396a04b1aee 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Air Mixture CARBON DIOXIDE-AIR MIXTURE Roberts Oxygen Company, Inc. 6a29bd9f-f47b-44dd-b5d0-a3b9bb51cf88 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Air AIR Roberts Oxygen Company, Inc. dfd24dc4-78dd-48a9-944e-64550ab76072 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Oxygen OXYGEN Roberts Oxygen Company, Inc. fd99ef4b-8a77-455d-b2a6-9a0d19a7b1fe 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Air Mixture CARBON DIOXIDE-AIR MIXTURE Roberts Oxygen Company, Inc. 71c939d8-9873-4e2b-be53-50d50eeb570f 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Oxygen OXYGEN Roberts Oxygen Company, Inc. c2b0f2bd-2ce2-4096-8aae-07d2200a015b 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE-OXYGEN MIXTURE Roberts Oxygen Company, Inc. b7311663-3c68-4879-a377-353e78ae4992 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE-OXYGEN MIXTURE Roberts Oxygen Company, Inc. b8a25034-6b65-4816-ac3c-e8a7a0fae5e2 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide-Air Mixture CARBON DIOXIDE-AIR MIXTURE Roberts Oxygen Company, Inc. be034e3c-526f-41cb-bfa0-88883232ea9b 2025-11-17 Exact identifier application applno (NDA): 205849 application number: NDA205849 OXYGEN OXYGEN Holston Gases, Inc. 941bef8d-ace4-438a-9cd5-b56fd5f5e214 2025-11-14 Exact identifier application applno (NDA): 205849 application number: NDA205849 OXYGEN OXYGEN RTA Pediatric Care Inc. b8da5aba-818c-4312-8579-f24ba5f65d7f 2025-11-11 Exact identifier application applno (NDA): 205849 application number: NDA205849 Carbon Dioxide/Oxygen Mix CARBON DIOXIDE/OXYGEN MIX NEXAIR, LLC 6b000266-aa36-4b0f-b4d1-f38e59d35c61 2025-10-31 Exact identifier application applno (NDA): 205849 application number: NDA205849 Helium/Oxygen Mix HELIUM/OXYGEN MIX NEXAIR, LLC 60dd4f4b-7132-385e-e053-2a91aa0ad5d6 2025-10-31 Exact identifier application applno (NDA): 205849 application number: NDA205849 ndc (product): 12213-801 Nitrogen Oxygen Mix NITROGEN OXYGEN MIX NexAir, LLC 7d4e17fc-825e-47c8-9bf4-d30c6aaa92c1 2025-10-31 Exact identifier application applno (NDA): 205849 application number: NDA205849 OXYGEN OXYGEN ANALGESIC SERVICES, INC. e704a9d2-9813-403c-9fde-a1a7510068b8 2025-10-29 Exact identifier application applno (NDA): 205849 application number: NDA205849 Oxygen OXYGEN Toll Company 07dccf95-bc1f-69a4-e063-6394a90a922b 2025-10-29 Exact identifier application applno (NDA): 205849 application number: NDA205849
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 12213-801-01 12213080101 5987.5 L in 1 CYLINDER (12213-801-01) 5987.5 l 1996-06-01 0000-00-00 No No Current 12213-801-02 12213080102 5774 L in 1 CYLINDER (12213-801-02) 5774 l 1996-06-01 0000-00-00 No No Current 12213-801-03 12213080103 6201 L in 1 CYLINDER (12213-801-03) 6201 l 1996-06-01 0000-00-00 No No Current 12213-801-04 12213080104 586 L in 1 CYLINDER (12213-801-04) 586 l 1996-06-01 0000-00-00 No No Current 12213-801-05 12213080105 5856 L in 1 CYLINDER (12213-801-05) 5856 l 1996-06-01 0000-00-00 No No Current 12213-801-06 12213080106 5938 L in 1 CYLINDER (12213-801-06) 5938 l 1996-06-01 0000-00-00 No No Current 12213-801-12 12213080112 5663 L in 1 CYLINDER (12213-801-12) 5663 l 1996-06-01 0000-00-00 No No Current 12213-801-13 12213080113 382 L in 1 CYLINDER (12213-801-13) 382 l 1996-06-01 0000-00-00 No No Current 12213-801-28 12213080128 561 L in 1 CYLINDER (12213-801-28) 561 l 1996-06-01 0000-00-00 No No Current