FDA.reportPublic FDA data

{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) } Pack

RxCUI
1550721
RxNorm name
{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) } Pack
Display name
{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) } Pack
Full name
{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) } Pack
Term type
GPCK
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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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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-77b29c59e91d{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) } PackGPCK12These 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 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) PackPSN12These 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