FDA.reportPublic FDA data

Allegra Allergy

Product NDC
41167-4122
11-digit product format
411674122
Labeler code
41167
Product ID
41167-4122_9bcf6745-5989-41ba-beef-1108fcecc020
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA020872
Marketing category
NDA
Marketing start
2014-12-17
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

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 997422

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
41167-4122-0Allegra Allergy8 in 1 BLISTER PACKTABLET, COATED819
41167-4122-0Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-2Allegra Allergy60 in 1 BOTTLETABLET, COATED6019
41167-4122-2Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-5Allegra Allergy24 in 1 BOTTLETABLET, COATED2419
41167-4122-5Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-6Allegra Allergy32 in 1 BOTTLETABLET, COATED3219
41167-4122-6Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-7Allegra Allergy40 in 1 BOTTLETABLET, COATED4019
41167-4122-9Allegra Allergy2 in 1 CARTONTABLET, COATED219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4122-0EA - Each41167-41223a35f0a5-0516-4e29-a8f2-88da4f8235ce12018-03-08
41167-4122-2EA - Each41167-41222518db29-f05b-49ba-a278-8aa86851b90312017-05-03
41167-4122-5EA - Each41167-4122f8d82f4f-f62c-48b9-b277-51aac0b33b2d12022-09-12
41167-4122-6EA - Each41167-41227928dbf2-5442-4ea3-a8ce-e360da62ca5d12022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4122ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]19Current NDC, Legacy NDC, 10 package rows20250221_f061d6b1-89f7-4d5f-ac59-9c73408517c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSNf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf061d6b1-89f7-4d5f-ac59-9c73408517c119
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf061d6b1-89f7-4d5f-ac59-9c73408517c119
997422Allegra 180 MG Oral TabletSYf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf061d6b1-89f7-4d5f-ac59-9c73408517c119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4122-0411674122001 BLISTER PACK in 1 CARTON (41167-4122-0) / 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2014-12-170000-00-00NoNoCurrent
41167-4122-2411674122021 BOTTLE in 1 CARTON (41167-4122-2) / 60 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-5411674122051 BOTTLE in 1 CARTON (41167-4122-5) / 24 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-6411674122061 BOTTLE in 1 CARTON (41167-4122-6) > 32 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-74116741220740 in 1 BOTTLEHistorical
41167-4122-9411674122092 in 1 CARTONHistorical