OXYGEN

Product NDC: 53622-001
11-digit product format: 536220001
Labeler code: 53622
Product ID: 53622-001_41ed70b2-529a-6cc3-e063-6394a90a4f06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYGEN
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Regional Home Care, Inc.
Application: NDA205865
Marketing category: NDA
Marketing start: 1982-01-01
Substance: OXYGEN
Active strength: 99 L/100L
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53622-001	53622-001-01	D	Discontinued by firm		2026-10-12
excluded package	package	53622-001	53622-001-02	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	53622-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	53622-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	53622-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	53622-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	53622-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	53622-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	53622-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	53622-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	53622-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	53622-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	53622-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	53622-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	53622-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	53622-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	53622-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	53622-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	53622-001-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	53622-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	53622-001-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	53622-001-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	53622-001-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	53622-001-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	53622-001-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	53622-001-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Ingredient	Strength
OXYGEN	99 L/100L

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
312172	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
7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53622-001-01	OXYGEN	21 L in 1 DEWAR	GAS	21	12
53622-001-02	OXYGEN	31 L in 1 DEWAR	GAS	31	12
53622-001-03	OXYGEN	36 L in 1 DEWAR	GAS	36	12
53622-001-04	OXYGEN	41 L in 1 DEWAR	GAS	41	12
53622-001-05	OXYGEN	46 L in 1 DEWAR	GAS	46	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
OXYGEN	ACTIVE INGREDIENT	S88TT14065	OXYGEN GAS [REGIONAL HOME CARE, INC.]	4
OXYGEN	ACTIVE MOIETY	S88TT14065	OXYGEN GAS [REGIONAL HOME CARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53622-001	OXYGEN GAS [REGIONAL HOME CARE, INC.]	11	Current NDC, Legacy NDC, 5 package rows	20241204_7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Oxygen	OXYGEN	VirtAir Inc.	beaf65dd-337d-4696-87c7-3237c7eec8fe	2025-10-27	Exact identifier application applno (NDA): 205865 application number: NDA205865
OXYGEN	OXYGEN	Regional Home Care, Inc.	7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba	2025-10-24	Exact identifier application applno (NDA): 205865 application number: NDA205865 ndc (product): 53622-001
Oxygen	OXYGEN	Depke Welding Supplies, Inc.	e81305b1-798d-4e16-8144-f96be15bdaf0	2025-10-21	Exact identifier application applno (NDA): 205865 application number: NDA205865
Oxygen	OXYGEN	CONROE WELDING SUPPLY, INC.	eb00b701-1d4b-39a7-e053-2a95a90af1c3	2025-10-09	Exact identifier application applno (NDA): 205865 application number: NDA205865
Oxygen	OXYGEN	Gallup Welders Supply, Inc.	d3b0a4c1-dd5e-4176-8560-09f392cb4b06	2025-10-06	Exact identifier application applno (NDA): 205865 application number: NDA205865
Oxygen	OXYGEN	Earlbeck Welding Supplies	c627c7c7-7a20-4413-bcb8-179fcfa2f2f0	2025-10-06	Exact identifier application applno (NDA): 205865 application number: NDA205865
OXYGEN	OXYGEN	Respiratory Care Partners, Inc	dc8d38dc-06de-4434-9f9c-8d7e76f815db	2024-10-28	Exact identifier application applno (NDA): 205865 application number: NDA205865
OXYGEN	OXYGEN	Atlas Welding Supply Co Inc	82baf417-8417-4df8-89d3-9d9f0e6382f2	2024-10-11	Exact identifier application applno (NDA): 205865 application number: NDA205865
AIR COMPRESSED	AIR COMPRESSED	Air Source Industries	f99447d4-50a3-437c-9754-f0945ede368a	2024-10-06	Exact identifier application applno (NDA): 205865 application number: NDA205865
OXYGEN	0XYGEN	Air Source Industries Inc	dbec9c5c-4656-4238-861a-986e8bd10e53	2024-10-06	Exact identifier application applno (NDA): 205865 application number: NDA205865
Oxygen	OXYGEN	Air Products and Chemicals, Inc.	3d0d7bdd-28d9-43d4-827c-4f6f4df6a8bc	2016-08-11	Exact identifier application applno (NDA): 205865 application number: NDA205865

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
312172	oxygen 99 % Gas for Inhalation	PSN	7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba	12
312172	oxygen 99 % Gas for Inhalation	SCD	7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53622-001-01	53622000101	21 L in 1 DEWAR	21 l					Historical
53622-001-02	53622000102	31 L in 1 DEWAR	31 l					Historical
53622-001-03	53622000103	36 L in 1 DEWAR (53622-001-03)	36 l	1982-01-01	0000-00-00	No	No	Current
53622-001-04	53622000104	41 L in 1 DEWAR (53622-001-04)	41 l	1982-01-01	0000-00-00	No	No	Current
53622-001-05	53622000105	46 L in 1 DEWAR (53622-001-05)	46 l	1982-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYGEN - Regional Home Care, Inc.	Regional Home Care, Inc.	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	12