FDA.reportPublic FDA data

Allergy Relief

Product NDC
69842-492
11-digit product format
698420492
Labeler code
69842
Product ID
69842-492_3c3140a8-78cd-1a9e-e063-6294a90a87bd
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-09-24
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 ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsExact 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
Allergy Relief
Listing expiration
2027-12-31

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
69842-492-02Allergy Relief1 in 1 CARTONTABLET13
69842-492-02Allergy Relief12 in 1 BLISTER PACKTABLET123
69842-492-03Allergy Relief12 in 1 BLISTER PACKTABLET123
69842-492-03Allergy Relief2 in 1 CARTONTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-492ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [CVS PHARMACY]2Current NDC, Legacy NDC, 4 package rows20210925_c77ee2bb-dc95-d8c9-e053-2995a90a9602.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNc77ee2bb-dc95-d8c9-e053-2995a90a96023
997501fexofenadine hydrochloride 60 MG Oral TabletSCDc77ee2bb-dc95-d8c9-e053-2995a90a96023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-492-02698420492021 BLISTER PACK in 1 CARTON (69842-492-02) / 12 TABLET in 1 BLISTER PACK1 blister pack2021-09-240000-00-00NoNoCurrent
69842-492-03698420492032 BLISTER PACK in 1 CARTON (69842-492-03) / 12 TABLET in 1 BLISTER PACK2 blister pack2021-09-240000-00-00NoNoCurrent