FDA.reportPublic FDA data

Oxygen

Product NDC
82457-001
Requested package NDC
82457-001-04
11-digit product format
824570001
Labeler code
82457
Product ID
82457-001_d35c609e-07de-1d58-e053-2a95a90a3138
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Toll Company
Application
NDA205849
Marketing category
NDA
Marketing start
2021-12-17
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
992 mL/L
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage82457-00182457-001-04IInactivated by FDA2026-10-05

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
82457-001-01Oxygen
82457-001-02Oxygen
82457-001-03Oxygen
82457-001-04Oxygen
82457-001-05Oxygen
82457-001-06Oxygen
82457-001-07Oxygen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82457-001-01Oxygen180 L in 1 DEWARGAS1801
82457-001-02Oxygen8495 L in 1 CYLINDERGAS84951
82457-001-03Oxygen7079 L in 1 CYLINDERGAS70791
82457-001-04Oxygen671 L in 1 CYLINDERGAS6711
82457-001-05Oxygen410 L in 1 CYLINDERGAS4101
82457-001-06Oxygen254 L in 1 CYLINDERGAS2541
82457-001-07Oxygen169 L in 1 CYLINDERGAS1691

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82457-001OXYGEN GAS [TOLL COMPANY]1Legacy NDC, 7 package rows20211222_d35c609e-07dd-1d58-e053-2a95a90a3138.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 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENChildrens Hospital of Philadelphia36b3f07a-d7f9-4d52-b40a-73d65e4f83ba2026-08-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348831oxygen 99.2 % Gas for InhalationPSNd35c609e-07dd-1d58-e053-2a95a90a31381
348831oxygen 99.2 % Gas for InhalationSCDd35c609e-07dd-1d58-e053-2a95a90a31381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82457-001-0482457000104671 L in 1 CYLINDER (82457-001-04) 671 l2021-12-170000-00-00NoNoCurrent