FDA.reportPublic FDA data

Oralair

Product NDC
59617-0010
11-digit product format
596170010
Labeler code
59617
Product ID
59617-0010_37291a56-277d-dd3a-e063-6294a90a7571
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
Stallergenes
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
100; 100; 100; 100; 100 [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
100 IR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTHOXANTHUM ODORATUM POLLEN100 [IR]/1
DACTYLIS GLOMERATA POLLEN100 [IR]/1
LOLIUM PERENNE POLLEN100 [IR]/1
PHLEUM PRATENSE POLLEN100 [IR]/1
POA PRATENSIS POLLEN100 [IR]/1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59617-0010-12020-12-02C16284748780-19d75b9d1-1fb0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use Initial U.S. Approval: 2014
59617-0010-12020-01-31C16284748780-19d75b9d1-1fb0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59617-0010-1Oralair100 IR3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING312
59617-0010-1Oralair100 IR1 in 1 BOXTABLET, ORALLY DISINTEGRATING112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59617-0010ORALAIR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN) KIT ORALAIR 100 IR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN) TABLET, ORALLY DISINTEGRATING ORALAIR 300 IR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN) TABLET, ORALLY DISINTEGRATING [STALLERGENES]11Current NDC, Legacy NDC, 2 package rows20241011_854c9772-63b9-44a3-a11e-77b29c59e91d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550722{3 (Kentucky 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]) / 6 (Kentucky 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]) } Pack [Oralair Children and Adolescents Sample Kit]BPCK854c9772-63b9-44a3-a11e-77b29c59e91d12
1550721{3 (Kentucky 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) / 6 (Kentucky 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) } PackGPCK854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
1550721Kentucky 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 (3) / Kentucky 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 (6) PackPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
1550707Oralair 100 IR Sublingual TabletPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
1550720Oralair 300 IR Sublingual TabletPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
1550722Oralair Children and Adolescents Sample KitPSN854c9772-63b9-44a3-a11e-77b29c59e91d12
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]SBD854c9772-63b9-44a3-a11e-77b29c59e91d12
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]SBD854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSCD854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSCD854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSY854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSY854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSY854c9772-63b9-44a3-a11e-77b29c59e91d12
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 TabletSY854c9772-63b9-44a3-a11e-77b29c59e91d12
1550720Oralair Adult Sample KitSY854c9772-63b9-44a3-a11e-77b29c59e91d12
1550722Oralair Children and Adolescents Sample Kit 9 Tablet PackSY854c9772-63b9-44a3-a11e-77b29c59e91d12
1550707Oralair Children and Adolescents Starter PackSY854c9772-63b9-44a3-a11e-77b29c59e91d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59617-0010-1596170010011 BLISTER PACK in 1 BOX (59617-0010-1) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-04-300000-00-00NoNoCurrent