FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
10014-003
11-digit product format
100140003
Labeler code
10014
Product ID
10014-003_423c874b-9b2a-21ee-e063-6294a90a5c17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Aero All Gas Company
Application
NDA206009
Marketing category
NDA
Marketing start
1972-10-06
Substance
NITROUS OXIDE
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.

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
Nitrous Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K50XQU1029Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312022Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd405eab-ac43-4590-975d-d0d1e8f78833Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10014-003-10Nitrous Oxide774 L in 1 CYLINDERGAS77416
10014-003-11Nitrous Oxide1651 L in 1 CYLINDERGAS165116
10014-003-12Nitrous Oxide4928 L in 1 CYLINDERGAS492816
10014-003-13Nitrous Oxide7391 L in 1 CYLINDERGAS739116
10014-003-14Nitrous Oxide13797 L in 1 CYLINDERGAS1379716
10014-003-15Nitrous Oxide91370 L in 1 DEWARGAS9137016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [AERO ALL GAS COMPANY]2
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [AERO ALL GAS COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10014-003NITROUS OXIDE GAS [AERO ALL GAS COMPANY]15Current NDC, Legacy NDC, 6 package rows20241012_bd405eab-ac43-4590-975d-d0d1e8f78833.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROUS OXIDENITROUS OXIDEAir Source Industrieseebd56c1-4ab3-409b-9767-e54dc42f2fce2024-10-06Exact identifier
application applno (NDA): 206009
application number: NDA206009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSNbd405eab-ac43-4590-975d-d0d1e8f7883316
312022nitrous oxide 99 % Gas for InhalationSCDbd405eab-ac43-4590-975d-d0d1e8f7883316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10014-003-1010014000310774 L in 1 CYLINDER (10014-003-10) 774 l1972-10-060000-00-00NoNoCurrent
10014-003-11100140003111651 L in 1 CYLINDER (10014-003-11) 1651 l1972-10-060000-00-00NoNoCurrent
10014-003-12100140003124928 L in 1 CYLINDER (10014-003-12) 4928 l1972-10-060000-00-00NoNoCurrent
10014-003-13100140003137391 L in 1 CYLINDER (10014-003-13) 7391 l1972-10-060000-00-00NoNoCurrent
10014-003-141001400031413797 L in 1 CYLINDER (10014-003-14) 13797 l1972-10-060000-00-00NoNoCurrent
10014-003-151001400031591370 L in 1 DEWAR (10014-003-15) 91370 l1972-10-060000-00-00NoNoCurrent