Allergy Relief

Product NDC
51316-801
11-digit product format
513160801
Labeler code
51316
Product ID
51316-801_93404a1d-ff78-4a5f-bf59-7323d78be195
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2023-01-30
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
51316-801-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET301
51316-801-30Allergy Relief1 in 1 BOXTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-801ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [CVS PHARMACY, INC]1Current NDC, 2 package rows20230217_57be0a69-9c5e-41a1-abd3-0b0e8a81093a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN57be0a69-9c5e-41a1-abd3-0b0e8a81093a1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD57be0a69-9c5e-41a1-abd3-0b0e8a81093a1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY57be0a69-9c5e-41a1-abd3-0b0e8a81093a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-801-30513160801301 BOTTLE, PLASTIC in 1 BOX (51316-801-30) / 30 TABLET in 1 BOTTLE, PLASTIC2023-01-30NoNoCurrent