Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

Manufacturer
Aidarex Pharmaceuticals LLC
Effective date
2014-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:05

Label at a glance#

Productfexofenadine hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Dosage and administration

 adults and children 12 years of age and over  take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours  children under 12 years of age  do not use  adults 65 years of age and older  ask a doctor  consumers with kidney disease  ask a doctor

Storage and handling

do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
 children under 12 years of age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Allegra® Allergy active ingredient

Fexofenadine Hydrochloride Tablets, 180 mg

Antihistamine

Non-Drowsy

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Original Prescription Strength

24 Hour

180 mg Each

Indoor & Outdoor Allergies

actual size

Allergy

IMAGE LABEL
IMAGE LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-228-902020-01-31C16284748780-19d75b9d0-49ea-f424-e053-dadaa90a57cePerrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-228-90fexofenadine hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-228FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140107_8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-228-90EA - Each33261-2281efd70fc-2a02-417f-a439-61f5ea3d3a6812015-10-02
45802-571-78EA - Each45802-571834cc3e1-09bf-4d4e-83ef-1022b7a7595b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZU1
FEXOFENADINEACTIVE MOIETYE6582LOH6V1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33261-22833261-228-90
45802-571

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
22 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE, COATED PELLETS / ORAL265 mgExact identifier — unii candidate
38 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, FOR SUSPENSION / ORAL2794 mgExact identifier — unii candidate
38 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER / ORAL50 mgExact identifier — unii candidate
38 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY47.5 mgExact identifier — unii candidate
38 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINHALANT / ORALNAExact identifier — unii candidate
38 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
38 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
30 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48INJECTION / INTRAMUSCULAR1 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS214 mgExact identifier — unii candidate
38 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS9.5 %w/vExact identifier — unii candidate
38 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076447-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-01
A076447-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-01
A076447-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-01
A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-0184e616aacf4f…
2026-09-14 22:38:342026-08A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-0184e616aacf4f…
2026-09-14 22:38:342026-08A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-0184e616aacf4f…
2026-09-14 22:38:342026-08A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1384e616aacf4f…
2026-08-18 06:07:402026-07A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-136a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076447-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076447-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076447-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
733d75a7-5111-47b2-a8c2-879fca5993c68e02f9b6-d5ca-42aa-bdb3-c9367745b5cd2014-01-01WarningsExact identifier
spl id: 733d75a7-5111-47b2-a8c2-879fca5993c6
spl set id: 8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.