FDA.reportPublic FDA data

Allergy Relief

Product NDC
42507-192
11-digit product format
425070192
Labeler code
42507
Product ID
42507-192_48494f6f-18ce-2479-e063-6394a90a09a9
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
HYVEE INC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2025-11-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

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
42507-192-03Allergy Relief5 in 1 BLISTER PACKTABLET53
42507-192-03Allergy Relief3 in 1 CARTONTABLET33
42507-192-07Allergy Relief60 in 1 BOTTLE, PLASTICTABLET603
42507-192-07Allergy Relief1 in 1 CARTONTABLET13
42507-192-09Allergy Relief1 in 1 CARTONTABLET13
42507-192-09Allergy Relief90 in 1 BOTTLE, PLASTICTABLET903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3e61ffb1-1c52-1ad5-e063-6294a90a6e3f3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3e61ffb1-1c52-1ad5-e063-6294a90a6e3f3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3e61ffb1-1c52-1ad5-e063-6294a90a6e3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42507-192-03425070192035 in 1 BLISTER PACKHistorical
42507-192-07425070192071 BOTTLE, PLASTIC in 1 CARTON (42507-192-07) / 60 TABLET in 1 BOTTLE, PLASTIC2026-01-13NoNoHistorical
42507-192-09425070192091 BOTTLE, PLASTIC in 1 CARTON (42507-192-09) / 90 TABLET in 1 BOTTLE, PLASTIC2026-01-13NoNoHistorical