FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
79481-6230
11-digit product format
794816230
Labeler code
79481
Product ID
79481-6230_4651835f-e421-131b-e063-6294a90a4042
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-07-01
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

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
Fexofenadine HCLFEXOFENADINE HCLMeijer, Inc.16de2c5d-b27b-9fb4-e063-6394a90a83902025-12-19WarningsExact 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

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCL
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
79481-6230-2Fexofenadine HCL24 in 1 BOTTLETABLET246
79481-6230-6Fexofenadine HCL60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-6230FEXOFENADINE HCL TABLET [MEIJER, INC.]3Current NDC, 2 package rows20250119_16de2c5d-b27b-9fb4-e063-6394a90a8390.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN16de2c5d-b27b-9fb4-e063-6394a90a83906
997420fexofenadine hydrochloride 180 MG Oral TabletSCD16de2c5d-b27b-9fb4-e063-6394a90a83906
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY16de2c5d-b27b-9fb4-e063-6394a90a83906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-6230-27948162300224 TABLET in 1 BOTTLE (79481-6230-2) 24 tablet2025-08-01NoNoCurrent
79481-6230-67948162300660 TABLET in 1 BOTTLE (79481-6230-6) 60 tablet2024-07-01NoNoCurrent