Allergy Relief

Product NDC
37808-391
11-digit product format
378080391
Labeler code
37808
Product ID
37808-391_e051ce8b-3163-69b9-e053-2a95a90ab739
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
HEB
Application
ANDA211075
Marketing category
ANDA
Marketing start
2022-05-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997501

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
37808-391-02Allergy Relief1 in 1 CARTONTABLET13
37808-391-02Allergy Relief12 in 1 BLISTER PACKTABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-391ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [HEB]3Current NDC, Legacy NDC, 2 package rows20220601_7cb25829-3aee-4a82-869d-ab4259626584.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSN7cb25829-3aee-4a82-869d-ab42596265843
997501fexofenadine hydrochloride 60 MG Oral TabletSCD7cb25829-3aee-4a82-869d-ab42596265843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-391-02378080391021 BLISTER PACK in 1 CARTON (37808-391-02) / 12 TABLET in 1 BLISTER PACK1 blister pack2022-05-310000-00-00NoNoCurrent