FDA.reportPublic FDA data

Oxygen-Nitrogen Mixture

Manufacturer
Roberts Oxygen Company, Inc.
Effective date
2025-11-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:46:14

Label at a glance#

ProductOxygen-Nitrogen Mixture
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPRESSED GAS, OXIDIZING, N.O.S.
(%%%)
UN3156
Rx only. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEART RATE. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure.
Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED. Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
CAS: , , ,. DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100 he o2 n2he o2 n2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
899763oxygen 80 % / nitrogen 20 % Gas for InhalationPSN2
899763nitrogen 20 % / oxygen 80 % Gas for InhalationSCD2
899763nitrogen (inactive) 20 % / oxygen 80 % Gas for InhalationSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46123-533-01Oxygen-Nitrogen Mixture6286 L in 1 CYLINDERGAS62862

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46123-53346123-533-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
NITROGENN762921K75IACT
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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
Oxygen-Nitrogen MixtureOXYGEN-NITROGEN MIXTURERoberts Oxygen Company, Inc.2bed62be-41d9-417f-e063-6394a90aeb282025-11-17Exact identifier
ndc (package): 46123-533-01
ndc (product): 46123-533
ndc11 (package): 46123053301
spl id: 43ced637-115e-0659-e063-6394a90a6810
spl set id: 2bed62be-41d9-417f-e063-6394a90aeb28

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.