FDA.reportPublic FDA data

Childrens Allegra Allergy

Product NDC
41167-4232
11-digit product format
411674232
Labeler code
41167
Product ID
41167-4232_44cdb5d9-8c36-41e1-af5a-35983ab0cc52
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA021909
Marketing category
NDA
Marketing start
2014-01-02
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 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
Childrens Allegra Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997482, 997484

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
41167-4232-1Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-1Childrens Allegra Allergy2 in 1 CARTONTABLET, ORALLY DISINTEGRATING216
41167-4232-6Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-6Childrens Allegra Allergy4 in 1 CARTONTABLET, ORALLY DISINTEGRATING416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4232-1EA - Each41167-42326d240a7a-34be-4ec9-8d4e-64c16914377c12014-07-02
41167-4232-6EA - Each41167-4232ade41b16-b68e-4f99-accc-afc2032c379812016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
FEXOFENADINEACTIVE MOIETYE6582LOH6VCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4232CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]16Current NDC, Legacy NDC, 4 package rows20250216_06115cea-5a44-409d-85ed-bb71743491c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997484Childrens Allegra Allergy 30 MG Disintegrating Oral TabletPSN06115cea-5a44-409d-85ed-bb71743491c116
997482fexofenadine HCl 30 MG Disintegrating Oral TabletPSN06115cea-5a44-409d-85ed-bb71743491c116
997484fexofenadine hydrochloride 30 MG Disintegrating Oral Tablet [Allegra]SBD06115cea-5a44-409d-85ed-bb71743491c116
997482fexofenadine hydrochloride 30 MG Disintegrating Oral TabletSCD06115cea-5a44-409d-85ed-bb71743491c116
997484Allegra 30 MG Disintegrating Oral TabletSY06115cea-5a44-409d-85ed-bb71743491c116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4232-1411674232012 BLISTER PACK in 1 CARTON (41167-4232-1) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2014-01-020000-00-00NoNoCurrent
41167-4232-6411674232064 BLISTER PACK in 1 CARTON (41167-4232-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2014-01-020000-00-00NoNoCurrent