FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
52086-015
11-digit product format
520860015
Labeler code
52086
Product ID
52086-015_436c1132-5ac7-b396-e063-6394a90adec4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Helget Gas Products
Application
NDA206014
Marketing category
NDA
Marketing start
1983-09-08
Substance
NITROUS OXIDE
Active strength
995 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
Nitrous Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE995 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
347046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8ea7d9d-d0c3-4ce4-a6e0-3ca0286d9795Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52086-015-01Nitrous Oxide13500 L in 1 CYLINDERGAS135009
52086-015-02Nitrous Oxide4900 L in 1 CYLINDERGAS49009
52086-015-03Nitrous Oxide1150 L in 1 CYLINDERGAS11509
52086-015-04Nitrous Oxide950 L in 1 CYLINDERGAS9509
52086-015-05Nitrous Oxide200 L in 1 CYLINDERGAS2009
52086-015-06Nitrous Oxide2400 L in 1 CYLINDERGAS24009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52086-015NITROUS OXIDE GAS [HELGET GAS PRODUCTS]8Current NDC, 6 package rows20241208_c8ea7d9d-d0c3-4ce4-a6e0-3ca0286d9795.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
Nitrous OxideNITROUS OXIDEHelget Gas Productsc8ea7d9d-d0c3-4ce4-a6e0-3ca0286d97952025-11-12Exact identifier
application applno (NDA): 206014
application number: NDA206014
ndc (product): 52086-015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347046nitrous oxide 99.5 % Gas for InhalationPSNc8ea7d9d-d0c3-4ce4-a6e0-3ca0286d97959
347046nitrous oxide 99.5 % Gas for InhalationSCDc8ea7d9d-d0c3-4ce4-a6e0-3ca0286d97959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52086-015-015208600150113500 L in 1 CYLINDER (52086-015-01) 13500 l1983-09-08NoNoCurrent
52086-015-02520860015024900 L in 1 CYLINDER (52086-015-02) 4900 l1983-09-08NoNoCurrent
52086-015-03520860015031150 L in 1 CYLINDER (52086-015-03) 1150 l1983-09-08NoNoCurrent
52086-015-0452086001504950 L in 1 CYLINDER (52086-015-04) 950 l1983-09-08NoNoCurrent
52086-015-0552086001505200 L in 1 CYLINDER (52086-015-05) 200 l1983-09-08NoNoCurrent
52086-015-06520860015062400 L in 1 CYLINDER (52086-015-06) 2400 l1983-09-08NoNoCurrent