Oxygen

Product NDC: 52563-002
11-digit product format: 525630002
Labeler code: 52563
Product ID: 52563-002_d18fd1df-0919-06f1-e053-2a95a90ade9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxygen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: T.W. Smith Corp.
Application: NDA205849
Marketing category: NDA
Marketing start: 1976-01-01
Marketing end: 0000-00-00
Substance: OXYGEN
Active strength: 100 mL/L
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 product	product	52563-002		D	Discontinued by firm		2026-10-05
excluded package	package	52563-002	52563-002-01	D	Discontinued by firm		2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52563-002-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52563-002-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52563-002-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52563-002-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52563-002-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52563-002-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52563-002-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52563-002-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52563-002-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52563-002-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52563-002-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52563-002-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52563-002-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52563-002-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52563-002-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52563-002-01	2025-11-19	C162847	48780-1	f386c649-ca7e-0266-e053-dadaa90a7c1a	oxygen
52563-002-01	2023-01-30	C162847	48780-1	f386c649-ca7e-0266-e053-dadaa90a7c1a	oxygen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52563-002	OXYGEN GAS [T.W. SMITH CORP.]	3	Legacy NDC	20211125_9a120f9e-cf10-6f26-e053-2995a90a5807.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 1 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
OXYGEN	OXYGEN	Childrens Hospital of Philadelphia	36b3f07a-d7f9-4d52-b40a-73d65e4f83ba	2026-08-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Empresas De Soldaduras	6f57cec9-9132-4ba4-a033-538c3a39ff9c	2026-07-27	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Advantage Respiratory Services	972755ee-f07f-485c-ba34-8e601f468512	2026-06-18	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	NexAir, LLC	aba44023-4919-4711-992c-aa59dfe366a9	2026-05-21	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Linde Gas & Equipment Inc.	a5bcde43-c0e8-4db8-bd4f-6f3af00b9b17	2026-04-20	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Albright Welding Supply Co., Inc.	80c05bc5-4918-4998-b5eb-4ca8b59bf716	2026-01-08	Exact identifier application applno (NDA): 205849 application number: NDA205849
Nitrogen	NITROGEN	Linde Puerto Rico B.V.	4e5df6ce-06ef-498f-b064-b2b6e1521951	2025-12-31	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Linde Inc.	58ca942f-16ba-49fe-a1aa-d62dddeaca6b	2025-12-30	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide Oxygen Mix	CARBON DIOXIDE OXYGEN MIX	Linde Gas & Equipment Inc.	b5f6d869-6875-4c82-9311-98a148790c0b	2025-12-19	Exact identifier application applno (NDA): 205849 application number: NDA205849
Air	AIR	General Air Service & Supply Co	60df0f08-6622-6cb5-e053-2a91aa0a7760	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Carbon Dioxide Oxygen Mixture	CARBON DIOXIDE OXYGEN MIXTURE	General Air Service & Supply Co	620d348d-75e6-3d1a-e053-2991aa0a855f	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen Nitrogen Mixture	OXYGEN NITROGEN MIXTURE	General Air Service & Supply Co.	c7f7500c-b521-4d93-a567-898ca4f778f4	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Helium/Oxygen Mixture 80/20	HELIUM/OXYGEN MIXTURE 80/20	General Air Service & Supply Co.	60df34a1-e3fa-6959-e053-2a91aa0a4760	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Helium/Oxygen Mixture 70/30	HELIUM/OXYGEN MIXTURE 70/30	General Air Service & Supply Co	620d5fe1-f7f1-8de7-e053-2a91aa0a8664	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	General Air Service & Supply Co	60399781-bcf4-4675-afb9-6d8b2670efa0	2025-11-26	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Oxarc, LLC	23eabc18-eded-466a-9524-6d0f0e483157	2025-11-25	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	General Cryogenic Technologies LLC	c071ca0b-a330-4579-a1b8-d4b4c5824a09	2025-11-21	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	T.W. Smith Corp.	35835f7d-2f1e-0e11-e063-6294a90ad526	2025-11-19	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Helium Mixture	OXYGEN-HELIUM MIXTURE	Roberts Oxygen Company, Inc.	2c3b2f64-cf21-d203-e063-6394a90a52de	2025-11-17	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen-Nitrogen Mixture	OXYGEN-NITROGEN MIXTURE	Roberts Oxygen Company, Inc.	2bed8d10-0a93-3c8a-e063-6294a90a9100	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52563-002-01	52563000201	127553 L in 1 DEWAR (52563-002-01)	127553 l	1976-01-01	0000-00-00	No	No	Current