Oxygen-Helium Mixture

Product NDC: 46123-511
11-digit product format: 461230511
Labeler code: 46123
Product ID: 46123-511_43ced524-6ac8-a310-e063-6294a90a29cd
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: 250 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	250 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
348600	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
2c3b199a-a2e7-1a7a-e063-6294a90a8d6b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46123-511-01	Oxygen-Helium Mixture	603 L in 1 CYLINDER	GAS	603		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46123-511	OXYGEN-HELIUM MIXTURE GAS [ROBERTS OXYGEN COMPANY, INC.]	1	Current NDC, 1 package rows	20250122_2c3b199a-a2e7-1a7a-e063-6294a90a8d6b.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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	2beb4f04-572d-4291-e063-6294a90a173a	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	2bead32e-888c-0c6a-e063-6294a90a3a61	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Air Mixture	CARBON DIOXIDE-AIR MIXTURE	Roberts Oxygen Company, Inc.	2be98fb6-ba91-f46c-e063-6294a90a28cf	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Roberts Oxygen Company, Inc.	af2c897d-7337-4467-b968-4a7e4794c5cc	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	c9fee13d-f4d5-445b-839a-d396a04b1aee	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Air Mixture	CARBON DIOXIDE-AIR MIXTURE	Roberts Oxygen Company, Inc.	6a29bd9f-f47b-44dd-b5d0-a3b9bb51cf88	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Air	AIR	Roberts Oxygen Company, Inc.	dfd24dc4-78dd-48a9-944e-64550ab76072	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Roberts Oxygen Company, Inc.	fd99ef4b-8a77-455d-b2a6-9a0d19a7b1fe	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Air Mixture	CARBON DIOXIDE-AIR MIXTURE	Roberts Oxygen Company, Inc.	71c939d8-9873-4e2b-be53-50d50eeb570f	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Roberts Oxygen Company, Inc.	c2b0f2bd-2ce2-4096-8aae-07d2200a015b	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	b7311663-3c68-4879-a377-353e78ae4992	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Oxygen Mixture	CARBON DIOXIDE-OXYGEN MIXTURE	Roberts Oxygen Company, Inc.	b8a25034-6b65-4816-ac3c-e8a7a0fae5e2	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide-Air Mixture	CARBON DIOXIDE-AIR MIXTURE	Roberts Oxygen Company, Inc.	be034e3c-526f-41cb-bfa0-88883232ea9b	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	Holston Gases, Inc.	941bef8d-ace4-438a-9cd5-b56fd5f5e214	2025-11-14	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	RTA Pediatric Care Inc.	b8da5aba-818c-4312-8579-f24ba5f65d7f	2025-11-11	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide/Oxygen Mix	CARBON DIOXIDE/OXYGEN MIX	NEXAIR, LLC	6b000266-aa36-4b0f-b4d1-f38e59d35c61	2025-10-31	Exact identifier application applno (NDA): 205849 application number: NDA205849
Helium/Oxygen Mix	HELIUM/OXYGEN MIX	NEXAIR, LLC	60dd4f4b-7132-385e-e053-2a91aa0ad5d6	2025-10-31	Exact identifier application applno (NDA): 205849 application number: NDA205849
Nitrogen Oxygen Mix	NITROGEN OXYGEN MIX	NexAir, LLC	7d4e17fc-825e-47c8-9bf4-d30c6aaa92c1	2025-10-31	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	ANALGESIC SERVICES, INC.	e704a9d2-9813-403c-9fde-a1a7510068b8	2025-10-29	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Toll Company	07dccf95-bc1f-69a4-e063-6394a90a922b	2025-10-29	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
348600	helium 75 % / oxygen 25 % Gas for Inhalation	PSN	2c3b199a-a2e7-1a7a-e063-6294a90a8d6b	2
348600	helium 75 % / oxygen 25 % Gas for Inhalation	SCD	2c3b199a-a2e7-1a7a-e063-6294a90a8d6b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46123-511-01	46123051101	603 L in 1 CYLINDER (46123-511-01)	603 l	1996-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxygen - Helium Mixture -511	Roberts Oxygen Company, Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	2