Oxygen-Helium Mixture

Product NDC: 46123-513
11-digit product format: 461230513
Labeler code: 46123
Product ID: 46123-513_43cecfee-3ea7-9e29-e063-6294a90aac6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxygen-Helium Mixture
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Roberts Oxygen Company, Inc.
Application: NDA205849
Marketing category: NDA
Marketing start: 1996-01-01
Substance: OXYGEN
Active strength: 330 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-Helium Mixture
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYGEN	330 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S88TT14065	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995446	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c3b2f64-cf1b-d203-e063-6394a90a52de	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46123-513-01	Oxygen-Helium Mixture	5805 L in 1 CYLINDER	GAS	5805		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46123-513	OXYGEN-HELIUM MIXTURE GAS [ROBERTS OXYGEN COMPANY, INC.]	1	Current NDC, 1 package rows	20250122_2c3b2f64-cf1b-d203-e063-6394a90a52de.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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Oxygen-Helium Mixture	OXYGEN-HELIUM MIXTURE	Roberts Oxygen Company, Inc.	2c3b1e14-622f-a6d2-e063-6394a90a0e6d	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Helium Mixture	OXYGEN-HELIUM MIXTURE	Roberts Oxygen Company, Inc.	2c3b2f64-cf1b-d203-e063-6394a90a52de	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849 ndc (product): 46123-513
Oxygen-Helium Mixture	OXYGEN-HELIUM MIXTURE	Roberts Oxygen Company, Inc.	2c3b199a-a2e7-1a7a-e063-6294a90a8d6b	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Helium Mixture	OXYGEN-HELIUM MIXTURE	Roberts Oxygen Company, Inc.	2c3aa397-b5c5-0809-e063-6294a90a8d01	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed62be-41d9-417f-e063-6394a90aeb28	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed62be-41dc-417f-e063-6394a90aeb28	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed4ff7-3696-ecfd-e063-6394a90ade34	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2becaa34-d392-6b84-e063-6394a90a1597	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed4ff7-369a-ecfd-e063-6394a90ade34	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bec9f82-7c8f-2c6b-e063-6294a90a9c32	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed87b2-9a52-65bc-e063-6294a90ae5f6	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed8d10-0a95-3c8a-e063-6294a90a9100	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed468a-e3d9-b92d-e063-6394a90a1bf9	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	2beb1e88-d6bb-b49a-e063-6394a90a1c72	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2beca3c8-c5b3-6e37-e063-6394a90a3497	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bec4cad-4216-a257-e063-6394a90a9881	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bec46ff-7f15-fdb2-e063-6294a90af0e8	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Carbon Dioxide Mixture	OXYGEN-CARBON DIOXIDE MIXTURE	Roberts Oxygen Company, Inc.	2bebc323-688f-a38a-e063-6294a90af33e	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Carbon Dioxide Mixture	OXYGEN-CARBON DIOXIDE MIXTURE	Roberts Oxygen Company, Inc.	2bebaa88-8222-6cd2-e063-6294a90ab4e5	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen-Nitrogen Mixture	CARBON DIOXIDE-OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bec64f5-2ed7-71b8-e063-6294a90af2f6	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S88TT14065	OXYGEN	7782-44-7	OXYGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995446	helium 67 % / oxygen 33 % Gas for Inhalation	PSN	2c3b2f64-cf1b-d203-e063-6394a90a52de	2
995446	helium 67 % / oxygen 33 % Gas for Inhalation	SCD	2c3b2f64-cf1b-d203-e063-6394a90a52de	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46123-513-01	46123051301	5805 L in 1 CYLINDER (46123-513-01)	5805 l	1996-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxygen - Helium Mixture -513	Roberts Oxygen Company, Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	2