FDA.reportPublic FDA data

Allergy Relief

Product NDC
0363-1847
11-digit product format
003631847
Labeler code
0363
Product ID
0363-1847_750c2665-b051-4585-94d7-70a9671796d2
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA212971
Marketing category
ANDA
Marketing start
2024-02-01
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
0363-1847-39Allergy Relief30 in 1 BOTTLETABLET, FILM COATED304
0363-1847-39Allergy Relief1 in 1 CARTONTABLET, FILM COATED14
0363-1847-49Allergy Relief40 in 1 BOTTLETABLET, FILM COATED404
0363-1847-49Allergy Relief1 in 1 CARTONTABLET, FILM COATED14
0363-1847-75Allergy Relief1 in 1 CARTONTABLET, FILM COATED14
0363-1847-75Allergy Relief90 in 1 BOTTLETABLET, FILM COATED904
0363-1847-95Allergy Relief45 in 1 BOTTLETABLET, FILM COATED454
0363-1847-95Allergy Relief1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1847ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]4Current NDC, 8 package rows20241215_99f03481-d169-4aac-8370-20011ff530ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN99f03481-d169-4aac-8370-20011ff530ea4
997420fexofenadine hydrochloride 180 MG Oral TabletSCD99f03481-d169-4aac-8370-20011ff530ea4
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY99f03481-d169-4aac-8370-20011ff530ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1847-39003631847391 BOTTLE in 1 CARTON (0363-1847-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-02-01NoNoCurrent
0363-1847-49003631847491 BOTTLE in 1 CARTON (0363-1847-49) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-13NoNoCurrent
0363-1847-75003631847751 BOTTLE in 1 CARTON (0363-1847-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-02-01NoNoCurrent
0363-1847-95003631847951 BOTTLE in 1 CARTON (0363-1847-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-02-01NoNoCurrent