FDA.reportPublic FDA data

Allergy Relief

Product NDC
69168-437
11-digit product format
691680437
Labeler code
69168
Product ID
69168-437_87568273-1744-4d82-a57f-8742b30d0122
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211075
Marketing category
ANDA
Marketing start
2022-05-18
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

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
Allergy Relief Non DrowsyFEXOFENADINE HCLAllegiant Health219606a8-9a3e-4c30-adb1-984f3f4e72c72022-05-19WarningsExact 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 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. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Brand name suffix
Non Drowsy
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
69168-437-06Allergy ReliefNon Drowsy120 in 1 BOTTLETABLET, FILM COATED1205
69168-437-98Allergy ReliefNon Drowsy200 in 1 BOTTLETABLET, FILM COATED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-437ALLERGY RELIEF NON DROWSY (FEXOFENADINE HCL) TABLET, FILM COATED [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 2 package rows20250515_219606a8-9a3e-4c30-adb1-984f3f4e72c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSN219606a8-9a3e-4c30-adb1-984f3f4e72c75
997501fexofenadine hydrochloride 60 MG Oral TabletSCD219606a8-9a3e-4c30-adb1-984f3f4e72c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-437-0669168043706120 TABLET, FILM COATED in 1 BOTTLE (69168-437-06) 2022-11-220000-00-00NoNoCurrent
69168-437-9869168043798200 TABLET, FILM COATED in 1 BOTTLE (69168-437-98) 2022-05-180000-00-00NoNoCurrent