FDA.reportPublic FDA data

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 Tablet

RxCUI
1550700
RxNorm name
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 Tablet
Display name
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 Tablet
Full name
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 Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125471OralairSweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
854c9772-63b9-44a3-a11e-77b29c59e91dAnthoxanthum 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 TabletSY12These 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: 201420250609
854c9772-63b9-44a3-a11e-77b29c59e91dKentucky 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 TabletSCD12These 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: 201420250609
854c9772-63b9-44a3-a11e-77b29c59e91dKentucky 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 TabletPSN12These 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: 201420250609
d44edb00-e1fa-2f20-e053-2a95a90a83f0Anthoxanthum 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 TabletSY1ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. Tablet for Sublingual Use Initial U.S. Approval: 201420211229
d44edb00-e1fa-2f20-e053-2a95a90a83f0Kentucky 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 TabletSCD1ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. Tablet for Sublingual Use Initial U.S. Approval: 201420211229
d44edb00-e1fa-2f20-e053-2a95a90a83f0Kentucky 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 TabletPSN1ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. Tablet for Sublingual Use Initial U.S. Approval: 201420211229