Allergy Relief

Product NDC
55319-965
11-digit product format
553190965
Labeler code
55319
Product ID
55319-965_695b2a8a-e614-4930-9471-12f66751223a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA211075
Marketing category
ANDA
Marketing start
2023-07-01
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
55319-965-15Allergy Relief1 in 1 BLISTER PACKTABLET15
55319-965-15Allergy Relief15 in 1 CARTONTABLET155
55319-965-30Allergy Relief1 in 1 BOXTABLET15
55319-965-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-965ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 4 package rows20230915_9d33bc80-696c-4f21-b38d-2cad0c1f09ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9d33bc80-696c-4f21-b38d-2cad0c1f09ad5
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9d33bc80-696c-4f21-b38d-2cad0c1f09ad5
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9d33bc80-696c-4f21-b38d-2cad0c1f09ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-965-155531909651515 BLISTER PACK in 1 CARTON (55319-965-15) / 1 TABLET in 1 BLISTER PACK15 blister pack2023-07-01NoNoHistorical
55319-965-30553190965301 BOTTLE, PLASTIC in 1 BOX (55319-965-30) / 30 TABLET in 1 BOTTLE, PLASTIC2023-07-01NoNoHistorical