FDA.reportPublic FDA data

Oxygen

Product NDC
11043-001
11-digit product format
110430001
Labeler code
11043
Product ID
11043-001_4476ac0d-cd1f-74ca-e063-6394a90a5713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
S. J. Smith Co., Inc.
Application
NDA205767
Marketing category
NDA
Marketing start
1986-01-01
Substance
OXYGEN
Active strength
992 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
OXYGEN992 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
348831Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89544705-5d9d-4595-8870-fa46c9c14af2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11043-001-01Oxygen154326 L in 1 DEWARGAS15432617
11043-001-02Oxygen7107 L in 1 CYLINDERGAS710717
11043-001-03Oxygen3539 L in 1 CYLINDERGAS353917
11043-001-04Oxygen651 L in 1 CYLINDERGAS65117
11043-001-05Oxygen396 L in 1 CYLINDERGAS39617
11043-001-06Oxygen141 L in 1 CYLINDERGAS14117
11043-001-07Oxygen127425 L in 1 DEWARGAS12742517
11043-001-08Oxygen145692 L in 1 DEWARGAS14569217
11043-001-09Oxygen9340 L in 1 CYLINDERGAS934017
11043-001-10Oxygen255 L in 1 CYLINDERGAS25517
11043-001-11Oxygen30 L in 1 CYLINDERGAS3017
11043-001-12Oxygen41 L in 1 CYLINDERGAS4117
11043-001-13Oxygen154326.81 L in 1 CANGAS154326.8117
11043-001-14Oxygen150 L in 1 CYLINDERGAS15017
11043-001-15Oxygen3831 L in 1 CYLINDERGAS383117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT14065OXYGEN GAS [S. J. SMITH CO., INC.]2
OXYGENACTIVE MOIETYS88TT14065OXYGEN GAS [S. J. SMITH CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11043-001OXYGEN GAS [S. J. SMITH CO., INC.]16Current NDC, Legacy NDC, 15 package rows20241012_89544705-5d9d-4595-8870-fa46c9c14af2.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
348831oxygen 99.2 % Gas for InhalationPSN89544705-5d9d-4595-8870-fa46c9c14af217
348831oxygen 99.2 % Gas for InhalationSCD89544705-5d9d-4595-8870-fa46c9c14af217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11043-001-0111043000101154326 L in 1 DEWAR (11043-001-01) 154326 l1986-01-010000-00-00NoNoCurrent
11043-001-02110430001027107 L in 1 CYLINDER (11043-001-02) 7107 l1986-01-010000-00-00NoNoCurrent
11043-001-03110430001033539 L in 1 CYLINDER (11043-001-03) 3539 l1986-01-010000-00-00NoNoCurrent
11043-001-0411043000104651 L in 1 CYLINDER (11043-001-04) 651 l1986-01-010000-00-00NoNoCurrent
11043-001-0511043000105396 L in 1 CYLINDER (11043-001-05) 396 l1986-01-010000-00-00NoNoCurrent
11043-001-0611043000106141 L in 1 CYLINDER (11043-001-06) 141 l1986-01-010000-00-00NoNoCurrent
11043-001-0711043000107127425 L in 1 DEWAR (11043-001-07) 127425 l1986-01-010000-00-00NoNoCurrent
11043-001-0811043000108145692 L in 1 DEWAR (11043-001-08) 145692 l1986-01-010000-00-00NoNoCurrent
11043-001-09110430001099340 L in 1 CYLINDER (11043-001-09) 9340 l1986-01-01NoNoCurrent
11043-001-1011043000110255 L in 1 CYLINDER (11043-001-10) 255 l1986-01-01NoNoCurrent
11043-001-111104300011130 L in 1 CYLINDER (11043-001-11) 30 l1986-01-01NoNoCurrent
11043-001-121104300011241 L in 1 CYLINDER (11043-001-12) 41 l1986-01-01NoNoCurrent
11043-001-1311043000113154326.81 L in 1 CAN (11043-001-13) 154326.81 l1986-01-01NoNoCurrent
11043-001-1411043000114150 L in 1 CYLINDER (11043-001-14) 150 l1986-01-01NoNoCurrent
11043-001-15110430001153831 L in 1 CYLINDER (11043-001-15) 3831 l1986-01-01NoNoCurrent