FDA.reportPublic FDA data

Allergy Relief

Product NDC
69168-450
11-digit product format
691680450
Labeler code
69168
Product ID
69168-450_ad7557a2-3e0a-4069-b1a2-250e97ca189e
Type
HUMAN OTC DRUG
Nonproprietary name
Allergy Relief
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA204097
Marketing category
ANDA
Marketing start
2024-04-17
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-450-06Allergy Relief120 in 1 BOTTLETABLET1204
69168-450-30Allergy Relief30 in 1 BOTTLETABLET304
69168-450-80Allergy Relief180 in 1 BOTTLETABLET1804
69168-450-82Allergy Relief90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-450ALLERGY RELIEF TABLET [ALLEGIANT HEALTH]3Current NDC, 4 package rows20250515_89ece1b5-7604-4dce-a8a6-df5b948e3cff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN89ece1b5-7604-4dce-a8a6-df5b948e3cff4
997420fexofenadine hydrochloride 180 MG Oral TabletSCD89ece1b5-7604-4dce-a8a6-df5b948e3cff4
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY89ece1b5-7604-4dce-a8a6-df5b948e3cff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-450-0669168045006120 TABLET in 1 BOTTLE (69168-450-06) 120 tablet2025-08-22NoNoHistorical
69168-450-306916804503030 TABLET in 1 BOTTLE (69168-450-30) 30 tablet2025-08-22NoNoHistorical
69168-450-8069168045080180 TABLET in 1 BOTTLE (69168-450-80) 180 tablet2024-04-17NoNoHistorical
69168-450-826916804508290 TABLET in 1 BOTTLE (69168-450-82) 90 tablet2024-04-17NoNoHistorical