FDA.reportPublic FDA data

Oralair

Product NDC
82454-0015
11-digit product format
824540015
Labeler code
82454
Product ID
82454-0015_d44ece12-6365-fef4-e053-2a95a90a0dec
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
SUBLINGUAL
Labeler
CENEXI HSC
Application
BLA125471
Marketing category
BLA
Marketing start
2014-04-30
Substance
ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
Active strength
300; 300; 300; 300; 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oralair
Brand name suffix
300 IR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTHOXANTHUM ODORATUM POLLEN300 [IR]/1
DACTYLIS GLOMERATA POLLEN300 [IR]/1
LOLIUM PERENNE POLLEN300 [IR]/1
PHLEUM PRATENSE POLLEN300 [IR]/1
POA PRATENSIS POLLEN300 [IR]/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82454-0015-2Oralair300 IR30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING301
82454-0015-3Oralair300 IR1 in 1 BOXTABLET, ORALLY DISINTEGRATING11
82454-0015-3Oralair300 IR3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82454-0015ORALAIR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN) KIT ORALAIR 300 IR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN) TABLET, ORALLY DISINTEGRATING [CENEXI HSC]1Current NDC, Legacy NDC, 3 package rows20211230_d44edb00-e1fa-2f20-e053-2a95a90a83f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550700Kentucky bluegrass pollen extract 100 IR / orchard grass pollen extract 100 IR / perennial rye grass pollen extract 100 IR / sweet vernal grass pollen extract 100 IR / Timothy grass pollen extract 100 IR Sublingual TabletPSNd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550713Kentucky bluegrass pollen extract 300 IR / orchard grass pollen extract 300 IR / perennial rye grass pollen extract 300 IR / sweet vernal grass pollen extract 300 IR / Timothy grass pollen extract 300 IR Sublingual TabletPSNd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550707Oralair 100 IR Sublingual TabletPSNd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550720Oralair 300 IR Sublingual TabletPSNd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550707Kentucky bluegrass pollen extract 100 IR / orchard grass pollen extract 100 IR / perennial rye grass pollen extract 100 IR / sweet vernal grass pollen extract 100 IR / Timothy grass pollen extract 100 IR Sublingual Tablet [Oralair 100]SBDd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550720Kentucky bluegrass pollen extract 300 IR / orchard grass pollen extract 300 IR / perennial rye grass pollen extract 300 IR / sweet vernal grass pollen extract 300 IR / Timothy grass pollen extract 300 IR Sublingual Tablet [Oralair 300]SBDd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550700Kentucky bluegrass pollen extract 100 IR / orchard grass pollen extract 100 IR / perennial rye grass pollen extract 100 IR / sweet vernal grass pollen extract 100 IR / Timothy grass pollen extract 100 IR Sublingual TabletSCDd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550713Kentucky bluegrass pollen extract 300 IR / orchard grass pollen extract 300 IR / perennial rye grass pollen extract 300 IR / sweet vernal grass pollen extract 300 IR / Timothy grass pollen extract 300 IR Sublingual TabletSCDd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550700Anthoxanthum odoratum grass pollen extract 100 IR / Dactylis glomerata pollen extract 100 IR / Lolium perenne grass pollen extract 100 IR / Phleum pratense grass pollen extract 100 IR / Poa pratensis grass pollen extract 100 IR Sublingual TabletSYd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550713Anthoxanthum odoratum grass pollen extract 300 IR / Dactylis glomerata pollen extract 300 IR / Lolium perenne grass pollen extract 300 IR / Phleum pratense grass pollen extract 300 IR / Poa pratensis grass pollen extract 300 IR Sublingual TabletSYd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550707Oralair 100 IR (Anthoxanthum odoratum grass pollen extract 100 IR / Dactylis glomerata pollen extract 100 IR / Lolium perenne grass pollen extract 100 IR / Phleum pratense grass pollen extract 100 IR / Poa pratensis grass pollen extract 100 IR) Sublingual TabletSYd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550720Oralair 300 IR (Anthoxanthum odoratum grass pollen extract 300 IR / Dactylis glomerata pollen extract 300 IR / Lolium perenne grass pollen extract 300 IR / Phleum pratense grass pollen extract 300 IR / Poa pratensis grass pollen extract 300 IR) Sublingual TabletSYd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550720Oralair Adult Sample KitSYd44edb00-e1fa-2f20-e053-2a95a90a83f01
1550707Oralair Children and Adolescents Starter PackSYd44edb00-e1fa-2f20-e053-2a95a90a83f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82454-0015-28245400150230 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (82454-0015-2) 2014-04-300000-00-00NoNoCurrent
82454-0015-3824540015031 BLISTER PACK in 1 BOX (82454-0015-3) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-04-300000-00-00NoNoCurrent