FDA.reportPublic FDA data

ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl

Product NDC
82725-1202
11-digit product format
827251202
Labeler code
82725
Product ID
82725-1202_47babe95-180f-19ec-e063-6394a90ae802
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA204097
Marketing category
ANDA
Marketing start
2025-11-01
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
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2016-08-19
A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2016-08-19
A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2016-08-19

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HClFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.f9ccd673-c65f-45c6-9863-26136eb816db2026-01-06WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product ■ do not take more than directed ■ do not take at the same time as aluminum or magnesium antacids ■ do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Additional Listing Data#

Finished product
Yes
Brand name base
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl
Listing expiration
2027-12-31

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
82725-1202-1ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl100 in 1 BOTTLETABLET1001
82725-1202-2ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl200 in 1 BOTTLETABLET2001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf9ccd673-c65f-45c6-9863-26136eb816db1
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf9ccd673-c65f-45c6-9863-26136eb816db1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf9ccd673-c65f-45c6-9863-26136eb816db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-1202-182725120201100 TABLET in 1 BOTTLE (82725-1202-1) 100 tablet2025-11-01NoNoCurrent
82725-1202-282725120202200 TABLET in 1 BOTTLE (82725-1202-2) 200 tablet2025-11-01NoNoCurrent