Allegra Allergy

Manufacturer
Chattem, Inc.
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
64
Source
full-release
Hydrated at
2026-06-01 01:53:35

Label at a glance#

ProductAllegra Allergy
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

 adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Allegra Allergy

Allegra Allergy® - 12/24 HOUR

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)
12 Hour Tablet: Fexofenadine HCl 60 mg

24 Hour Tablet: 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
  • sneezing
  • itchy, watery eyes
  • 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.

Allegra 12 Hour Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take
more than 2 tablets in 24 hours
 children under 12 years of agedo not use
 adults 65 years of age and olderask a doctor
 consumers with kidney diseaseask a doctor

Allegra 24 Hour Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened or if inner foil seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-8 66 - 844 - 2798 or www.allegra.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4131-4
Allegra
ALLERGY
60 mg/ antihistamine
12 HR
24 TABLETS

NDC 41167-4131-4 Allegra ALLERGY 60 mg/ antihistamine 12 HR 24 TABLETSNDC 41167-4131-4 Allegra ALLERGY 60 mg/ antihistamine 12 HR 24 TABLETS

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4120-3
Allegra
ALLERGY
180 mg/ antihistamine
24 HR
30 TABLETS

NDC 41167-4120-3 Allegra ALLERGY 180 mg/ antihistamine 24 HR 30 TABLETSNDC 41167-4120-3 Allegra ALLERGY 180 mg/ antihistamine 24 HR 30 TABLETS

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4120-3
Allegra
ALLERGY
180 mg/antihistamine
24 HR
30 TABLETS

NDC 41167-4120-3 Allegra ALLERGY 180 mg/antihistamine 24 HR 30 TABLETSNDC 41167-4120-3 Allegra ALLERGY 180 mg/antihistamine 24 HR 30 TABLETS

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
40 TABLETS

Allegra ALLERGY 180 mg/ antihistamine 24 HR 40 TABLETSAllegra ALLERGY 180 mg/ antihistamine 24 HR 40 TABLETS

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
90 TABLETS

Allegra ALLERGY 180 mg/ antihistamine 24 HR 90 TABLETSAllegra ALLERGY 180 mg/ antihistamine 24 HR 90 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997422Allegra 180 MG Oral TabletPSN64
997502Allegra Allergy 60 MG Oral TabletPSN64
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN64
997501fexofenadine HCl 60 MG Oral TabletPSN64
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD64
997502fexofenadine hydrochloride 60 MG Oral Tablet [Allegra]SBD64
997420fexofenadine hydrochloride 180 MG Oral TabletSCD64
997501fexofenadine hydrochloride 60 MG Oral TabletSCD64
997422Allegra 180 MG Oral TabletSY64
997502Allegra 60 MG Oral TabletSY64
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY64

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4120-0Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-0Allegra Allergy5 in 1 BLISTER PACKTABLET, FILM COATED564
41167-4120-1Allegra Allergy2 in 1 BLISTER PACKTABLET, FILM COATED264
41167-4120-1Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-2Allegra Allergy5 in 1 BLISTER PACKTABLET, FILM COATED564
41167-4120-2Allegra Allergy3 in 1 CARTONTABLET, FILM COATED364
41167-4120-3Allegra Allergy30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3064
41167-4120-3Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-4Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-4Allegra Allergy45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4564
41167-4120-5Allegra Allergy45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4564
41167-4120-5Allegra Allergy2 in 1 CARTONTABLET, FILM COATED264
41167-4120-6Allegra Allergy70 in 1 BOTTLE, PLASTICTABLET, FILM COATED7064
41167-4120-6Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4121-0Allegra Allergy1 in 1 PACKAGETABLET, FILM COATED164
41167-4121-0Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED164
41167-4121-1Allegra Allergy60 in 1 BOTTLETABLET, FILM COATED6064
41167-4121-1Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4121-2Allegra Allergy2 in 1 POUCHTABLET, FILM COATED264
41167-4121-2Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED164
41167-4121-3Allegra Allergy2 in 1 PACKAGETABLET, FILM COATED264
41167-4121-3Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED164
41167-4121-4Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4121-4Allegra Allergy40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4064
41167-4121-5Allegra Allergy2 in 1 CARTONTABLET, FILM COATED264
41167-4121-5Allegra Allergy30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3064
41167-4121-6Allegra Allergy37 in 1 BOTTLE, PLASTICTABLET, FILM COATED3764
41167-4121-6Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4121-7Allegra Allergy54 in 1 BOTTLE, PLASTICTABLET, FILM COATED5464
41167-4121-7Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-0Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-0Allegra Allergy90 in 1 BOTTLETABLET, FILM COATED9064
41167-4124-3Allegra Allergy2 in 1 PACKAGETABLET, FILM COATED264
41167-4124-5Allegra Allergy55 in 1 BOTTLETABLET, FILM COATED5564
41167-4124-7Allegra Allergy84 in 1 BOTTLETABLET, FILM COATED8464
41167-4124-7Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-8Allegra Allergy100 in 1 BOTTLETABLET, FILM COATED10064
41167-4124-8Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4131-2Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-2Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4131-4Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-4Allegra Allergy2 in 1 CARTONTABLET, FILM COATED264
41167-4131-6Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-6Allegra Allergy3 in 1 CARTONTABLET, FILM COATED364

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4131-2EA - Each41167-4131f40b438f-4e9c-42a9-bed9-1b1e1cc0924812012-07-24
41167-4131-4EA - Each41167-4131f4b5b52c-1585-4aab-b8f0-d93706d2637112015-03-03
41167-4120-0EA - Each41167-4120a319bd76-8ddf-44b6-b1cc-2ba117185f6d12012-07-24
41167-4120-2EA - Each41167-412056bcf949-12a0-42c0-b487-9d700456915b12012-07-24
41167-4120-3EA - Each41167-41203a70589e-d283-4343-a1e4-566c12814ee612012-07-24
41167-4120-4EA - Each41167-4120496e2b39-5506-46c2-a111-be6de6cd017612012-07-24
41167-4120-5EA - Each41167-4120dca89411-559c-49cc-903c-a7966c80475e12012-07-24
41167-4120-6EA - Each41167-41203244b127-7096-4dff-9e71-8410ec8d785412012-07-24
41167-4121-4EA - Each41167-412191535d6e-251a-4379-a228-62464885496e12022-09-12
41167-4124-0EA - Each41167-4124d0d30baa-eca0-4e55-860a-4f0cc7069c9a12022-09-12
41167-4124-3EA - Each41167-41248cb7279c-fe40-4a52-85a4-50def71f52ce12023-03-13
41167-4124-7EA - Each41167-41245cd50192-8f0e-404f-99cd-bd64b88033a212022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZU29
FEXOFENADINEACTIVE MOIETYE6582LOH6V29
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U29
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH4829
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO29
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3029
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A29
POVIDONESINACTIVE INGREDIENTFZ989GH94E29
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU429
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ29
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP29

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
632026-01-12monthly-update2026-06-03 17:51:38
622024-11-01full-release2026-06-01 00:37:28

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 4 · 216 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
27 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020872-005CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24
N020872-006CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALRLD2011-01-24
N020872-007ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-008ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-009ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24
N020872-010ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2484e616aacf4f…
2026-08-18 06:07:402026-07N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…

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
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd1732026-04-14WarningsExact identifier
ndc (package): 41167-4121-1
ndc (package): 41167-4131-2
ndc (package): 41167-4131-4
ndc (package): 41167-4121-0
ndc (package): 41167-4120-4
ndc (package): 41167-4120-1
ndc (package): 41167-4124-7
ndc (package): 41167-4120-6
ndc (package): 41167-4121-5
ndc (package): 41167-4124-3
ndc (package): 41167-4124-8
ndc (package): 41167-4124-0
ndc (package): 41167-4124-5
ndc (package): 41167-4120-2
ndc (package): 41167-4121-4
ndc (package): 41167-4131-6
ndc (package): 41167-4120-3
ndc (package): 41167-4121-6
ndc (package): 41167-4121-7
ndc (package): 41167-4120-0
ndc (package): 41167-4120-5
ndc (package): 41167-4121-2
ndc (package): 41167-4121-3
ndc (product): 41167-4124
ndc (product): 41167-4121
ndc (product): 41167-4131
ndc (product): 41167-4120
ndc11 (package): 41167412408
ndc11 (package): 41167412101
ndc11 (package): 41167412001
ndc11 (package): 41167412003
ndc11 (package): 41167412103
ndc11 (package): 41167412004
ndc11 (package): 41167413106
ndc11 (package): 41167412106
ndc11 (package): 41167412000
ndc11 (package): 41167412006
ndc11 (package): 41167412102
ndc11 (package): 41167413104
ndc11 (package): 41167412403
ndc11 (package): 41167412107
ndc11 (package): 41167412002
ndc11 (package): 41167412005
ndc11 (package): 41167412405
ndc11 (package): 41167412400
ndc11 (package): 41167412407
ndc11 (package): 41167412100
ndc11 (package): 41167413102
ndc11 (package): 41167412104
ndc11 (package): 41167412105
spl id: fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff
spl set id: 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173

Reported adverse events (FAERS/openFDA)#

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