Allergy Relief

Product NDC
69168-437
11-digit product format
691680437
Labeler code
69168
Product ID
69168-437_87568273-1744-4d82-a57f-8742b30d0122
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211075
Marketing category
ANDA
Marketing start
2022-05-18
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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
Brand name suffix
Non Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997501

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
69168-437-06Allergy ReliefNon Drowsy120 in 1 BOTTLETABLET, FILM COATED1205
69168-437-98Allergy ReliefNon Drowsy200 in 1 BOTTLETABLET, FILM COATED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-437ALLERGY RELIEF NON DROWSY (FEXOFENADINE HCL) TABLET, FILM COATED [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 2 package rows20250515_219606a8-9a3e-4c30-adb1-984f3f4e72c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSN219606a8-9a3e-4c30-adb1-984f3f4e72c75
997501fexofenadine hydrochloride 60 MG Oral TabletSCD219606a8-9a3e-4c30-adb1-984f3f4e72c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-437-0669168043706120 TABLET, FILM COATED in 1 BOTTLE (69168-437-06) 2022-11-220000-00-00NoNoCurrent
69168-437-9869168043798200 TABLET, FILM COATED in 1 BOTTLE (69168-437-98) 2022-05-180000-00-00NoNoCurrent