FDA.reportPublic FDA data

Oxygen

Product NDC
52438-011
11-digit product format
524380011
Labeler code
52438
Product ID
52438-011_4f81eb61-b968-b1a6-e063-6294a90a9932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Messer LLC
Application
NDA205767
Marketing category
NDA
Marketing start
1960-01-01
Substance
OXYGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
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
Oxygen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN995 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
312173Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0de4fe56-80c8-06be-da02-b145e0a5dbf2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52438-011-20Oxygen18144 L in 1 TANKGAS1814421

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN (OXYGEN) GAS [LINDE LLC]8
OxygenACTIVE MOIETYS88TT14065OXYGEN (OXYGEN) GAS [LINDE LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52438-011OXYGEN (OXYGEN) GAS [MESSER LLC]18Current NDC, Legacy NDC, 1 package rows20241019_0de4fe56-80c8-06be-da02-b145e0a5dbf2.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
312173oxygen 99.5 % Gas for InhalationPSN0de4fe56-80c8-06be-da02-b145e0a5dbf221
312173oxygen 99.5 % Gas for InhalationSCD0de4fe56-80c8-06be-da02-b145e0a5dbf221
312173oxygen 99.5 % Gas for InhalationPSNd810b2ee-0e09-e952-e053-2a95a90afeca5
312173oxygen 99.5 % Gas for InhalationSCDd810b2ee-0e09-e952-e053-2a95a90afeca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52438-011-205243800112018144 L in 1 TANK (52438-011-20) 18144 l1960-01-010000-00-00NoNoCurrent