Oxygen

Product NDC: 80421-100
11-digit product format: 804210100
Labeler code: 80421
Product ID: 80421-100_579dba0f-f81e-8f9a-e063-6294a90a76b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxygen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Empresas De Soldaduras
Application: NDA205849
Marketing category: NDA
Marketing start: 2020-07-01
Substance: OXYGEN
Active strength: 1 L/L
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 54 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80421-100-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80421-100-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80421-100-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80421-100-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80421-100-01	I	Inactivated by FDA	`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	80421-100-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80421-100-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80421-100-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80421-100-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80421-100-01	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	80421-100-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80421-100-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80421-100-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80421-100-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80421-100-01	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	80421-100-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80421-100-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80421-100-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80421-100-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80421-100-01	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	80421-100-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80421-100-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80421-100-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80421-100-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80421-100-01	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	80421-100-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80421-100-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80421-100-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80421-100-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80421-100-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80421-100-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80421-100-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80421-100-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80421-100-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80421-100-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80421-100-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80421-100-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80421-100-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80421-100-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80421-100-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80421-100-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80421-100-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80421-100-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80421-100-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80421-100-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYGEN	1 L/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
542304	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
6f57cec9-9132-4ba4-a033-538c3a39ff9c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
80421-100-01	Empresas de Soladuras - Oxygen
80421-100-01	Empresas de Soladuras - Oxygen
80421-100-01	Empresas de Soladuras - Oxygen
80421-100-02	Empresas de Soladuras - Oxygen
80421-100-02	Empresas de Soladuras - Oxygen
80421-100-02	Empresas de Soladuras - Oxygen
80421-100-03	Empresas de Soladuras - Oxygen
80421-100-03	Empresas de Soladuras - Oxygen
80421-100-03	Empresas de Soladuras - Oxygen
80421-100-04	Empresas de Soladuras - Oxygen
80421-100-04	Empresas de Soladuras - Oxygen
80421-100-04	Empresas de Soladuras - Oxygen
80421-100-05	Empresas de Soladuras - Oxygen
80421-100-05	Empresas de Soladuras - Oxygen
80421-100-05	Empresas de Soladuras - Oxygen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80421-100-01	Oxygen	400 L in 1 CYLINDER	GAS	400	6
80421-100-02	Oxygen	670 L in 1 CYLINDER	GAS	670	6
80421-100-03	Oxygen	3570 L in 1 CYLINDER	GAS	3570	6
80421-100-04	Oxygen	7160 L in 1 TANK	GAS	7160	6
80421-100-05	Oxygen	8580 L in 1 TANK	GAS	8580	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80421-100	OXYGEN GAS [EMPRESAS DE SOLDADURAS]	6	Current NDC, Legacy NDC, 5 package rows	20231019_6f57cec9-9132-4ba4-a033-538c3a39ff9c.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 4 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
OXYGEN	OXYGEN	Oxygen Service Company, Inc	4ee1406d-3707-8491-e063-6394a90a7dd5	2025-10-28	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	HOWARDS MEDICAL LLC	84649a92-90f6-3862-e053-2991aa0a4287	2025-10-24	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	DuPuy Oxygen & Supply Company, Inc.	23ea9464-b667-4114-90c8-418d75edd2e6	2025-10-24	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Reliance Bottle Gas Company Inc. dba Reliance Oxygen & Equipment Co.	1b0dd4b5-73d3-4bc0-a97f-ca895f74db50	2025-10-24	Exact identifier application applno (NDA): 205849 application number: NDA205849
Heliox	HELIOX	Metro Welding Supply Corporation	8529d8a5-8675-b1a4-e053-2a91aa0a914c	2025-10-20	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Metro Welding Supply Corporation	a019fa1c-7d2f-47cb-a5bc-986bef2fe025	2025-10-20	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Ali-Rob, Inc. dba Southern Oxygen & Welding Supply	7b552d38-2338-415b-9d7f-ca6cc1b25aeb	2025-10-13	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Bill Munn Supply, Inc.	d7acff02-d828-4fe5-9208-86e865dfee17	2025-10-09	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Medical Comfort Systems Inc	9f9cb81e-1f28-4091-8a69-17eb6a3bc1c3	2025-10-08	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	General Welding Supply Corp.	f37b377a-9d6d-46f6-9129-6ec61a71f9d9	2025-10-06	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	Central-McGowan, Inc.	924d0ba9-8105-4434-aff9-e798b9541ee2	2024-11-04	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	South Jersey Welding Supply	c5353ec5-f51a-4342-a212-ecf1aed564fe	2024-10-28	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	James Supplies, L.L.c	f7a942ff-253a-4024-969d-c8a80bca581e	2024-10-27	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	Gilmore Liquid Air Co.	03fbd6e5-09a6-4f13-b251-63cf9ff129e9	2024-10-21	Exact identifier application applno (NDA): 205849 application number: NDA205849
OXYGEN	OXYGEN	Greenville Truck and Welding Supplies LLC	e88af3f0-5bf6-4d5f-abfb-4ab75fed03d8	2024-10-21	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Huber Supply Co. Inc.	2d9a54b2-842e-4e8c-8b90-d585418bb5c3	2024-10-21	Exact identifier application applno (NDA): 205849 application number: NDA205849
Oxygen	OXYGEN	Biomedics Systems, Inc.	31fa43d7-af18-44cf-b95e-6e27834bd24e	2024-10-12	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
542304	oxygen 100 % Gas for Inhalation	PSN	6f57cec9-9132-4ba4-a033-538c3a39ff9c	6
542304	oxygen 100 % Gas for Inhalation	SCD	6f57cec9-9132-4ba4-a033-538c3a39ff9c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80421-100-01	80421010001	400 L in 1 CYLINDER (80421-100-01)	400 l	2020-07-01	0000-00-00	No	No	Current
80421-100-02	80421010002	670 L in 1 CYLINDER (80421-100-02)	670 l	2020-07-01	0000-00-00	No	No	Current
80421-100-03	80421010003	3570 L in 1 CYLINDER (80421-100-03)	3570 l	2020-07-01	0000-00-00	No	No	Current
80421-100-04	80421010004	7160 L in 1 TANK (80421-100-04)	7160 l	2020-07-01	0000-00-00	No	No	Current
80421-100-05	80421010005	8580 L in 1 TANK (80421-100-05)	8580 l	2020-07-01	0000-00-00	No	No	Current