FDA.reportPublic FDA data

Oxygen

Product NDC
53683-0001
Requested package NDC
53683-0001-8
11-digit product format
536830001
Labeler code
53683
Product ID
53683-0001_47317ad1-0379-c236-e063-6394a90ab118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Medox Corporation
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2009-10-16
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN99 L/100L

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
312172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5baca5cc-47a4-4a01-bf1f-7ebc5e225326Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53683-0001-1Oxygen180 L in 1 CYLINDERGAS18017
53683-0001-2Oxygen240 L in 1 CYLINDERGAS24017
53683-0001-3Oxygen415 L in 1 CYLINDERGAS41517
53683-0001-4Oxygen682 L in 1 CYLINDERGAS68217
53683-0001-5Oxygen640 L in 1 CYLINDERGAS64017
53683-0001-6Oxygen1738 L in 1 CYLINDERGAS173817
53683-0001-7Oxygen3455 L in 1 CYLINDERGAS345517
53683-0001-8Oxygen7080 L in 1 CYLINDERGAS708017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [MEDOX CORPORATION]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [MEDOX CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53683-0001OXYGEN GAS [MEDOX CORPORATION]16Current NDC, Legacy NDC, 8 package rows20241023_5baca5cc-47a4-4a01-bf1f-7ebc5e225326.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENMedox Corporation5baca5cc-47a4-4a01-bf1f-7ebc5e2253262025-12-30Exact identifier
ndc (package): 53683-0001-8
ndc (product): 53683-0001
ndc11 (package): 53683000108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN5baca5cc-47a4-4a01-bf1f-7ebc5e22532617
312172oxygen 99 % Gas for InhalationSCD5baca5cc-47a4-4a01-bf1f-7ebc5e22532617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53683-0001-8536830001087080 L in 1 CYLINDER (53683-0001-8) 7080 l2009-10-160000-00-00NoNoCurrent