FDA.reportPublic FDA data

Oralair Adult Sample Kit

RxCUI
1550720
RxNorm name
Oralair Adult Sample Kit
Display name
Oralair Adult Sample Kit
Full name
Oralair Adult Sample Kit
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)Rx2026-08-01

RxNav Current And Historical NDCs#

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

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 300 IR Sublingual Tablet [PSN] · 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] [SBD] · Oralair 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 Tablet [SY] · Oralair Adult Sample Kit [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 300 IR Sublingual Tablet [PSN] · 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] [SBD] · Oralair 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 Tablet [SY] · Oralair Adult Sample Kit [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