FDA.reportPublic FDA data

Oxygen

Product NDC
75828-001
Requested package NDC
75828-001-12
11-digit product format
758280001
Labeler code
75828
Product ID
75828-001_57a2c6bb-dd3b-9161-e063-6394a90a4488
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Pure-Ox, LLC
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2002-01-30
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
81691365-6b04-549a-e053-2a91aa0a0555Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75828-001-01Oxygen113 L in 1 CYLINDERGAS11311
75828-001-02Oxygen165 L in 1 CYLINDERGAS16511
75828-001-03Oxygen164 L in 1 CYLINDERGAS16411
75828-001-04Oxygen198 L in 1 CYLINDERGAS19811
75828-001-05Oxygen255 L in 1 CYLINDERGAS25511
75828-001-06Oxygen425 L in 1 CYLINDERGAS42511
75828-001-07Oxygen640 L in 1 CYLINDERGAS64011
75828-001-08Oxygen680 L in 1 CYLINDERGAS68011
75828-001-09Oxygen1738 L in 1 CYLINDERGAS173811
75828-001-10Oxygen3455 L in 1 CYLINDERGAS345511
75828-001-11Oxygen7080 L in 1 CYLINDERGAS708011
75828-001-12Oxygen247 L in 1 DEWARGAS24711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75828-001OXYGEN GAS [PURE-OX, LLC]10Current NDC, Legacy NDC, 12 package rows20241228_81691365-6b04-549a-e053-2a91aa0a0555.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
OxygenOXYGENPure-Ox, LLC81691365-6b04-549a-e053-2a91aa0a05552026-07-27Exact identifier
ndc (package): 75828-001-12
ndc (product): 75828-001
ndc11 (package): 75828000112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN81691365-6b04-549a-e053-2a91aa0a055511
312172oxygen 99 % Gas for InhalationSCD81691365-6b04-549a-e053-2a91aa0a055511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75828-001-1275828000112247 L in 1 DEWAR (75828-001-12) 247 l2002-01-300000-00-00NoNoCurrent