FDA.reportPublic FDA data

RECONSTITUTED AIR

Product NDC
84120-005
11-digit product format
841200005
Labeler code
84120
Product ID
84120-005_40d3cfb2-9110-7949-e063-6394a90af65b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RECONSTITUTED AIR
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WSM SUPPLIER LLC.
Application
NDA205889
Marketing category
NDA
Marketing start
2024-05-07
Substance
OXYGEN
Active strength
210 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.

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
RECONSTITUTED AIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN210 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
347123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17e3afd9-e900-1d44-e063-6294a90a0472Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84120-005-01RECONSTITUTED AIR408 L in 1 CYLINDERGAS4083
84120-005-02RECONSTITUTED AIR665 L in 1 CYLINDERGAS6653
84120-005-03RECONSTITUTED AIR2305 L in 1 CYLINDERGAS23053
84120-005-04RECONSTITUTED AIR2608 L in 1 CYLINDERGAS26083
84120-005-05RECONSTITUTED AIR3030 L in 1 CYLINDERGAS30303
84120-005-06RECONSTITUTED AIR3092.2 L in 1 CYLINDERGAS3092.23
84120-005-07RECONSTITUTED AIR5376 L in 1 CYLINDERGAS53763
84120-005-08RECONSTITUTED AIR5912 L in 1 CYLINDERGAS59123
84120-005-09RECONSTITUTED AIR6032 L in 1 CYLINDERGAS60323
84120-005-10RECONSTITUTED AIR6598 L in 1 CYLINDERGAS65983
84120-005-11RECONSTITUTED AIR6739 L in 1 CYLINDERGAS67393
84120-005-12RECONSTITUTED AIR7334 L in 1 CYLINDERGAS73343
84120-005-13RECONSTITUTED AIR8070 L in 1 CYLINDERGAS80703
84120-005-14RECONSTITUTED AIR8807 L in 1 CYLINDERGAS88073

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84120-005RECONSTITUTED AIR GAS [WSM SUPPLIER LLC.]2Current NDC, 14 package rows20241204_17e3afd9-e900-1d44-e063-6294a90a0472.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 3 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AirAIRFresno Oxygen and Welding Suppliers, Inc.60cc8727-2b78-3cdb-e053-2991aa0a64e12025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENFresno Oxygen & Welding Suppliers Inc201cee91-cd54-49b8-aa97-932d74aa004b2025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENClovis Equipment & Supply Company55373dd8-3a52-439d-b4f0-649b237f57e82025-10-23Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWSM SUPPLIER LLC.17e3afd9-e900-1d44-e063-6294a90a04722025-10-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
ndc (product): 84120-005
OXYGENOXYGENCrumpton Welding Supply & Equipment, Inc.8c6b984d-2ace-4534-b441-c2db959a1da12025-02-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENEastern Welding Supply, Inc.6ee3107c-6cd3-4171-aef7-a7ac033ab3b12024-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AIR COMPRESSEDAIR COMPRESSEDCrumpton Welding Supply & Equipment, Inc.6ab929ae-a49c-4b6b-9f66-91f3463e3ed52024-10-15Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ebb98-d27f-188b-e053-2a91aa0a0a692020-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ec89f-4ba3-68cd-e053-2991aa0a6a5c2020-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347123nitrogen 79 % / oxygen 21 % Gas for InhalationPSN17e3afd9-e900-1d44-e063-6294a90a04723
347123nitrogen 79 % / oxygen 21 % Gas for InhalationSCD17e3afd9-e900-1d44-e063-6294a90a04723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84120-005-0184120000501408 L in 1 CYLINDER (84120-005-01) 408 l2024-05-07NoNoCurrent
84120-005-0284120000502665 L in 1 CYLINDER (84120-005-02) 665 l2024-05-07NoNoCurrent
84120-005-03841200005032305 L in 1 CYLINDER (84120-005-03) 2305 l2024-05-07NoNoCurrent
84120-005-04841200005042608 L in 1 CYLINDER (84120-005-04) 2608 l2024-05-07NoNoCurrent
84120-005-05841200005053030 L in 1 CYLINDER (84120-005-05) 3030 l2024-05-07NoNoCurrent
84120-005-06841200005063092.2 L in 1 CYLINDER (84120-005-06) 3092.2 l2024-05-07NoNoCurrent
84120-005-07841200005075376 L in 1 CYLINDER (84120-005-07) 5376 l2024-05-07NoNoCurrent
84120-005-08841200005085912 L in 1 CYLINDER (84120-005-08) 5912 l2024-05-07NoNoCurrent
84120-005-09841200005096032 L in 1 CYLINDER (84120-005-09) 6032 l2024-05-07NoNoCurrent
84120-005-10841200005106598 L in 1 CYLINDER (84120-005-10) 6598 l2024-05-07NoNoCurrent
84120-005-11841200005116739 L in 1 CYLINDER (84120-005-11) 6739 l2024-05-07NoNoCurrent
84120-005-12841200005127334 L in 1 CYLINDER (84120-005-12) 7334 l2024-05-07NoNoCurrent
84120-005-13841200005138070 L in 1 CYLINDER (84120-005-13) 8070 l2024-05-07NoNoCurrent
84120-005-14841200005148807 L in 1 CYLINDER (84120-005-14) 8807 l2024-05-07NoNoCurrent