Allergy Relief

Product NDC
81522-613
11-digit product format
815220613
Labeler code
81522
Product ID
81522-613_e66bde41-c733-47c5-aeb3-b07ac5b9e007
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FSA Store Inc. (Caring Mills)
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-10-08
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

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
81522-613-30Allergy Relief1 in 1 BOXTABLET, COATED13
81522-613-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-613ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [FSA STORE INC. (CARING MILLS)]3Current NDC, Legacy NDC, 2 package rows20240125_d33f15db-0e5e-4515-b7a7-cb2760469ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd33f15db-0e5e-4515-b7a7-cb2760469ac13
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd33f15db-0e5e-4515-b7a7-cb2760469ac13
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd33f15db-0e5e-4515-b7a7-cb2760469ac13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-613-30815220613301 BOTTLE, PLASTIC in 1 BOX (81522-613-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2021-10-080000-00-00NoNoCurrent