FDA.reportPublic FDA data

Helium

Product NDC
10297-006
11-digit product format
102970006
Labeler code
10297
Product ID
10297-006_41d953d1-5988-866b-e063-6294a90a36ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
A-OX Welding Supply, LLC
Application
NDA211781
Marketing category
NDA
Marketing start
2018-06-01
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
7046ef16-a4f4-15b7-e053-2a91aa0a4f1aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10297-006-01Helium85 L in 1 CYLINDERGAS8510
10297-006-02Helium623 L in 1 CYLINDERGAS62310
10297-006-03Helium6201 L in 1 CYLINDERGAS620110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10297-006HELIUM GAS [A-OX WELDING SUPPLY CO., INC.]9Current NDC, Legacy NDC, 3 package rows20241208_7046ef16-a4f4-15b7-e053-2a91aa0a4f1a.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMA-OX Welding Supply, LLC7046ef16-a4f4-15b7-e053-2a91aa0a4f1a2025-10-23Exact identifier
application applno (NDA): 211781
application number: NDA211781
ndc (product): 10297-006
HeliumHELIUMMachine & Welding Supply Company dba Arc3 Gases South44ff03e6-f79d-eb6c-e063-6294a90aba5b2024-12-06Exact identifier
application applno (NDA): 211781
application number: NDA211781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN7046ef16-a4f4-15b7-e053-2a91aa0a4f1a10
310693helium 99 % Gas for InhalationSCD7046ef16-a4f4-15b7-e053-2a91aa0a4f1a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10297-006-011029700060185 L in 1 CYLINDER (10297-006-01) 85 l2018-06-010000-00-00NoNoCurrent
10297-006-0210297000602623 L in 1 CYLINDER (10297-006-02) 623 l2018-06-010000-00-00NoNoCurrent
10297-006-03102970006036201 L in 1 CYLINDER (10297-006-03) 6201 l2018-06-010000-00-00NoNoCurrent