FDA.reportPublic FDA data

Helium

Product NDC
46123-800
11-digit product format
461230800
Labeler code
46123
Product ID
46123-800_43cecff0-1ded-dece-e063-6394a90a8c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Roberts Oxygen Company, Inc.
Application
NDA213609
Marketing category
NDA
Marketing start
1967-01-01
Substance
HELIUM
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
IngredientStrength
HELIUM990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206GF3GB41Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310693Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
554faa48-7fc2-4d1a-b223-82cf107b144fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46123-800-01Helium102 L in 1 CYLINDERGAS1027
46123-800-02Helium374 L in 1 CYLINDERGAS3747
46123-800-03Helium623 L in 1 CYLINDERGAS6237
46123-800-04Helium3880 L in 1 CYLINDERGAS38807
46123-800-05Helium5436 L in 1 CYLINDERGAS54367
46123-800-06Helium6910 L in 1 CYLINDERGAS69107
46123-800-07Helium8241 L in 1 CYLINDERGAS82417

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]1
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46123-800HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]6Current NDC, 7 package rows20250122_554faa48-7fc2-4d1a-b223-82cf107b144f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMRoberts Oxygen Company, Inc.554faa48-7fc2-4d1a-b223-82cf107b144f2025-11-17Exact identifier
application applno (NDA): 213609
application number: NDA213609
ndc (product): 46123-800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN554faa48-7fc2-4d1a-b223-82cf107b144f7
310693helium 99 % Gas for InhalationSCD554faa48-7fc2-4d1a-b223-82cf107b144f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46123-800-0146123080001102 L in 1 CYLINDER (46123-800-01) 102 l1967-01-01NoNoCurrent
46123-800-0246123080002374 L in 1 CYLINDER (46123-800-02) 374 l1967-01-01NoNoCurrent
46123-800-0346123080003623 L in 1 CYLINDER (46123-800-03) 623 l1967-01-01NoNoCurrent
46123-800-04461230800043880 L in 1 CYLINDER (46123-800-04) 3880 l1967-01-01NoNoCurrent
46123-800-05461230800055436 L in 1 CYLINDER (46123-800-05) 5436 l1967-01-01NoNoCurrent
46123-800-06461230800066910 L in 1 CYLINDER (46123-800-06) 6910 l1967-01-01NoNoCurrent
46123-800-07461230800078241 L in 1 CYLINDER (46123-800-07) 8241 l1967-01-01NoNoCurrent