FDA.reportPublic FDA data

oxygen

Product NDC
54767-001
11-digit product format
547670001
Labeler code
54767
Product ID
54767-001_4500baaa-0a61-0f95-e063-6294a90a1bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Shaw Oxygen Company Inc
Application
NDA205767
Marketing category
NDA
Marketing start
2010-09-14
Substance
OXYGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
287f2a22-daea-4d64-80a7-2f825852c6a7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54767-001-09oxygen424 L in 1 CYLINDERGAS42416
54767-001-14oxygen283 L in 1 CYLINDERGAS28316
54767-001-31oxygen3538 L in 1 CYLINDERGAS353816
54767-001-37oxygen7107 L in 1 CYLINDERGAS710716
54767-001-40oxygen8693 L in 1 CYLINDERGAS869316
54767-001-74oxygen39573 L in 1 DEWARGAS3957316
54767-001-80oxygen141868 L in 1 DEWARGAS14186816

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [SHAW OXYGEN COMPANY INC]5
oxygenACTIVE MOIETYS88TT14065OXYGEN GAS [SHAW OXYGEN COMPANY INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54767-001OXYGEN GAS [SHAW OXYGEN COMPANY INC]15Current NDC, Legacy NDC, 7 package rows20241120_287f2a22-daea-4d64-80a7-2f825852c6a7.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 InhalationPSN287f2a22-daea-4d64-80a7-2f825852c6a716
312173oxygen 99.5 % Gas for InhalationSCD287f2a22-daea-4d64-80a7-2f825852c6a716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54767-001-0954767000109424 L in 1 CYLINDER (54767-001-09) 424 l2010-09-140000-00-00NoNoCurrent
54767-001-1454767000114283 L in 1 CYLINDER (54767-001-14) 283 l2010-09-140000-00-00NoNoCurrent
54767-001-31547670001313538 L in 1 CYLINDER (54767-001-31) 3538 l2010-09-140000-00-00NoNoCurrent
54767-001-37547670001377107 L in 1 CYLINDER (54767-001-37) 7107 l2010-09-140000-00-00NoNoCurrent
54767-001-40547670001408693 L in 1 CYLINDER (54767-001-40) 8693 l2010-09-140000-00-00NoNoCurrent
54767-001-745476700017439573 L in 1 DEWAR (54767-001-74) 39573 l2010-09-140000-00-00NoNoCurrent
54767-001-8054767000180141868 L in 1 DEWAR (54767-001-80) 141868 l2010-09-140000-00-00NoNoCurrent