FDA.reportPublic FDA data

Oralair 100 IR Sublingual Tablet

RxCUI
1550707
RxNorm name
Oralair 100 IR Sublingual Tablet
Display name
Oralair 100 IR Sublingual Tablet
Full name
Oralair 100 IR Sublingual Tablet
Term type
PSN
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)Rx2026-08-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
854c9772-63b9-44a3-a11e-77b29c59e91dOralair 100 IR Sublingual Tablet [PSN] · 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] [SBD] · Oralair 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 Tablet [SY] · Oralair Children and Adolescents Starter Pack [SY]412These 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-e053-2a95a90a83f0Oralair 100 IR Sublingual Tablet [PSN] · 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] [SBD] · Oralair 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 Tablet [SY] · Oralair Children and Adolescents Starter Pack [SY]41ORALAIR® (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