HELIUM

Product NDC: 42602-002
Requested package NDC: 42602-002-04
11-digit product format: 426020002
Labeler code: 42602
Product ID: 42602-002_98d996ba-6551-4cf7-b28d-088a76dcbccf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HELIUM
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Norco, Inc.
Application: NDA205819
Marketing category: NDA
Marketing start: 2008-09-01
Substance: HELIUM
Active strength: 99 L/100L
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: 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
e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42602-002-01	HELIUM	595 L in 1 CYLINDER	GAS	595	8
42602-002-02	HELIUM	6202 L in 1 CYLINDER	GAS	6202	8
42602-002-03	HELIUM	368 L in 1 CYLINDER	GAS	368	8
42602-002-04	HELIUM	142 L in 1 CYLINDER	GAS	142	8
42602-002-05	HELIUM	1530 L in 1 CYLINDER	GAS	1530	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
HELIUM	ACTIVE INGREDIENT	206GF3GB41	HELIUM GAS [NORCO, INC.]	3
HELIUM	ACTIVE MOIETY	206GF3GB41	HELIUM GAS [NORCO, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42602-002	HELIUM GAS [NORCO, INC.]	7	Current NDC, Legacy NDC, 5 package rows	20240517_e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Helium	HELIUM	AGL Inhalation Therapy Co.	b309a459-c8bc-4ac3-a4e2-3989a63be8a9	2026-03-02		Exact identifier application applno (NDA): 205819 application number: NDA205819
HELIUM	HELIUM	Norco, Inc.	e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c	2025-08-31		Exact identifier application applno (NDA): 205819 application number: NDA205819 ndc (package): 42602-002-04 ndc (product): 42602-002 ndc11 (package): 42602000204

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	e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c	8
310693	helium 99 % Gas for Inhalation	SCD	e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42602-002-04	42602000204	142 L in 1 CYLINDER (42602-002-04)	142 l	2008-09-01	0000-00-00	No	No	Current