FDA.reportPublic FDA data

Oxygen

Product NDC
53452-001
11-digit product format
534520001
Labeler code
53452
Product ID
53452-001_44721c96-8375-6c0f-e063-6294a90aa532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Dale Oxygen And Acetylene Service, Inc
Application
NDA205767
Marketing category
NDA
Marketing start
1963-01-01
Substance
OXYGEN
Active strength
990 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
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
43d1f68d-874b-4cbc-94ff-fd498cc9f2c1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53452-001-01Oxygen420 L in 1 CYLINDERGAS42011
53452-001-02Oxygen690 L in 1 CYLINDERGAS69011
53452-001-03Oxygen3160 L in 1 CYLINDERGAS316011
53452-001-04Oxygen6900 L in 1 CYLINDERGAS690011
53452-001-05Oxygen165 L in 1 CYLINDERGAS16511
53452-001-06Oxygen249 L in 1 CYLINDERGAS24911
53452-001-07Oxygen210 L in 1 CYLINDERGAS21011
53452-001-08Oxygen2265 L in 1 CYLINDERGAS226511
53452-001-09Oxygen200 L in 1 DEWARGAS20011
53452-001-10Oxygen80 L in 1 DEWARGAS8011
53452-001-11Oxygen30 L in 1 DEWARGAS3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53452-001OXYGEN GAS [DALE OXYGEN AND ACETYLENE SERVICE, INC]10Current NDC, Legacy NDC, 11 package rows20241023_43d1f68d-874b-4cbc-94ff-fd498cc9f2c1.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
312172oxygen 99 % Gas for InhalationPSN43d1f68d-874b-4cbc-94ff-fd498cc9f2c111
312172oxygen 99 % Gas for InhalationSCD43d1f68d-874b-4cbc-94ff-fd498cc9f2c111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53452-001-0153452000101420 L in 1 CYLINDER (53452-001-01) 420 l1963-01-010000-00-00NoNoCurrent
53452-001-0253452000102690 L in 1 CYLINDER (53452-001-02) 690 l1963-01-010000-00-00NoNoCurrent
53452-001-03534520001033160 L in 1 CYLINDER (53452-001-03) 3160 l1963-01-010000-00-00NoNoCurrent
53452-001-04534520001046900 L in 1 CYLINDER (53452-001-04) 6900 l1963-01-010000-00-00NoNoCurrent
53452-001-0553452000105165 L in 1 CYLINDER (53452-001-05) 165 l1963-01-010000-00-00NoNoCurrent
53452-001-0653452000106249 L in 1 CYLINDER (53452-001-06) 249 l1963-01-010000-00-00NoNoCurrent
53452-001-0753452000107210 L in 1 CYLINDER (53452-001-07) 210 l1963-01-010000-00-00NoNoCurrent
53452-001-08534520001082265 L in 1 CYLINDER (53452-001-08) 2265 l1963-01-010000-00-00NoNoCurrent
53452-001-0953452000109200 L in 1 DEWAR (53452-001-09) 200 l1963-01-010000-00-00NoNoCurrent
53452-001-105345200011080 L in 1 DEWAR (53452-001-10) 80 l1963-01-010000-00-00NoNoCurrent
53452-001-115345200011130 L in 1 DEWAR (53452-001-11) 30 l1963-01-010000-00-00NoNoCurrent