FDA.reportPublic FDA data

Oxygen

Product NDC
85812-001
11-digit product format
858120001
Labeler code
85812
Product ID
85812-001_52e25d46-cb2f-1f82-e063-6394a90a5204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Gulf Coast Gas & Equipment, LLC
Application
NDA205767
Marketing category
NDA
Marketing start
2025-06-30
Substance
OXYGEN
Active strength
990 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
OXYGEN990 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
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
374cdd84-3d25-28b3-e063-6394a90a9f24Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85812-001-01Oxygen420 L in 1 CYLINDERGAS4202
85812-001-02Oxygen690 L in 1 CYLINDERGAS6902
85812-001-03Oxygen3470 L in 1 CYLINDERGAS34702
85812-001-04Oxygen7060 L in 1 CYLINDERGAS70602
85812-001-05Oxygen8510 L in 1 CYLINDERGAS85102
85812-001-06Oxygen180 L in 1 CYLINDERGAS1802

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
312172oxygen 99 % Gas for InhalationPSN374cdd84-3d25-28b3-e063-6394a90a9f242
312172oxygen 99 % Gas for InhalationSCD374cdd84-3d25-28b3-e063-6394a90a9f242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85812-001-0185812000101420 L in 1 CYLINDER (85812-001-01) 420 l2025-06-30NoNoCurrent
85812-001-0285812000102690 L in 1 CYLINDER (85812-001-02) 690 l2025-06-30NoNoCurrent
85812-001-03858120001033470 L in 1 CYLINDER (85812-001-03) 3470 l2025-06-30NoNoCurrent
85812-001-04858120001047060 L in 1 CYLINDER (85812-001-04) 7060 l2025-06-30NoNoCurrent
85812-001-05858120001058510 L in 1 CYLINDER (85812-001-05) 8510 l2025-06-30NoNoCurrent
85812-001-0685812000106180 L in 1 CYLINDER (85812-001-06) 180 l2025-06-30NoNoCurrent