HELIUM

Product NDC: 10167-300
11-digit product format: 101670300
Labeler code: 10167
Product ID: 10167-300_bbffc3c2-c49f-4215-8e74-0a2e7a92e3cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HELIUM
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Air Source Industries Inc
Application: NDA205843
Marketing category: NDA
Marketing start: 1992-01-01
Substance: HELIUM
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10167-300	10167-300-04	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: HELIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HELIUM	99 L/100L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206GF3GB41	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310693	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
7d1d5963-8b7f-4d8d-807a-6b9f896c7171	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10167-300-01	HELIUM	610 L in 1 CYLINDER	GAS	610	12
10167-300-02	HELIUM	5800 L in 1 CYLINDER	GAS	5800	12
10167-300-03	HELIUM	6160 L in 1 CYLINDER	GAS	6160	12
10167-300-04	HELIUM	161 L in 1 CYLINDER	GAS	161	12
10167-300-05	HELIUM	166 L in 1 CYLINDER	GAS	166	12
10167-300-06	HELIUM	370 L in 1 CYLINDER	GAS	370	12
10167-300-07	HELIUM	2780 L in 1 CYLINDER	GAS	2780	12
10167-300-08	HELIUM	1557 L in 1 CYLINDER	GAS	1557	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
HELIUM	ACTIVE INGREDIENT	206GF3GB41	HELIUM GAS [AIR SOURCE INDUSTRIES INC]	2
HELIUM	ACTIVE MOIETY	206GF3GB41	HELIUM GAS [AIR SOURCE INDUSTRIES INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10167-300	HELIUM GAS [AIR SOURCE INDUSTRIES INC]	12	Current NDC, Legacy NDC, 8 package rows	20241008_7d1d5963-8b7f-4d8d-807a-6b9f896c7171.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Helium	HELIUM	WSM SUPPLIER LLC.	153317bb-7f55-0964-e063-6394a90a2922	2025-10-08	Exact identifier application applno (NDA): 205843 application number: NDA205843
HELIUM	HELIUM	AIRGAS USA, LLC	61d7bc2a-a22d-4640-99ee-9737d39d07fe	2025-09-03	Exact identifier application applno (NDA): 205843 application number: NDA205843
HELIUM	HELIUM	Air Source Industries Inc	7d1d5963-8b7f-4d8d-807a-6b9f896c7171	2024-10-06	Exact identifier application applno (NDA): 205843 application number: NDA205843 ndc (product): 10167-300
Helium, Oxygen	HELIUM, OXYGEN	AIRGAS USA, LLC	8485f6f4-f322-4b82-abff-47e64c713f1b	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843
Helium, Oxygen	HELIUM, OXYGEN	AIRGAS USA, LLC	58ba729f-cca1-4e08-a131-dbe91258d99d	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843
Helium Oxygen mixture	HELIUM OXYGEN MIXTURE	Airgas Usa, LLC	df74ce02-cbf4-49b3-8456-dc4fa7ddc9be	2024-10-01	Exact identifier application applno (NDA): 205843 application number: NDA205843

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
206GF3GB41	HELIUM	7440-59-7	HELIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310693	helium 99 % Gas for Inhalation	PSN	7d1d5963-8b7f-4d8d-807a-6b9f896c7171	12
310693	helium 99 % Gas for Inhalation	SCD	7d1d5963-8b7f-4d8d-807a-6b9f896c7171	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10167-300-01	10167030001	610 L in 1 CYLINDER (10167-300-01)	610 l	1992-01-01	0000-00-00	No	No	Current
10167-300-02	10167030002	5800 L in 1 CYLINDER (10167-300-02)	5800 l	1992-01-01	0000-00-00	No	No	Current
10167-300-03	10167030003	6160 L in 1 CYLINDER (10167-300-03)	6160 l	1992-01-01	0000-00-00	No	No	Current
10167-300-04	10167030004	161 L in 1 CYLINDER (10167-300-04)	161 l	1992-01-01	0000-00-00	No	No	Current
10167-300-05	10167030005	166 L in 1 CYLINDER (10167-300-05)	166 l	1992-01-01	0000-00-00	No	No	Current
10167-300-06	10167030006	370 L in 1 CYLINDER (10167-300-06)	370 l	1992-01-01	0000-00-00	No	No	Current
10167-300-07	10167030007	2780 L in 1 CYLINDER (10167-300-07)	2780 l	1992-01-01	0000-00-00	No	No	Current
10167-300-08	10167030008	1557 L in 1 CYLINDER (10167-300-08)	1557 l	1992-01-01	0000-00-00	No	No	Current