FDA.reportPublic FDA data

Childrens Allegra Allergy

Product NDC
41167-4246
11-digit product format
411674246
Labeler code
41167
Product ID
41167-4246_606e69ed-df38-4228-942d-a2625c26a803
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA201373
Marketing category
NDA
Marketing start
2011-03-03
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allegra Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997491, 997493

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4246-2Childrens Allegra Allergy240 mL in 1 BOTTLESUSPENSION24027
41167-4246-2Childrens Allegra Allergy1 in 1 CARTONSUSPENSION127
41167-4246-4Childrens Allegra Allergy1 in 1 CARTONSUSPENSION127
41167-4246-4Childrens Allegra Allergy120 mL in 1 BOTTLESUSPENSION12027

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
FEXOFENADINEACTIVE MOIETYE6582LOH6VCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4246CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [CHATTEM, INC.]26Current NDC, 4 package rows20241011_e2bd23c7-dfba-463a-adbe-2183970da740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997493Allegra 30 MG in 5 mL Oral SuspensionPSNe2bd23c7-dfba-463a-adbe-2183970da74027
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSNe2bd23c7-dfba-463a-adbe-2183970da74027
997493fexofenadine hydrochloride 6 MG/ML Oral Suspension [Allegra]SBDe2bd23c7-dfba-463a-adbe-2183970da74027
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCDe2bd23c7-dfba-463a-adbe-2183970da74027
997493Allegra 30 MG per 5 ML Oral SuspensionSYe2bd23c7-dfba-463a-adbe-2183970da74027
997493Allegra 6 MG/ML Oral SuspensionSYe2bd23c7-dfba-463a-adbe-2183970da74027
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSYe2bd23c7-dfba-463a-adbe-2183970da74027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-4246-2411674246021 BOTTLE in 1 CARTON (41167-4246-2) / 240 mL in 1 BOTTLE1 bottle2023-03-01NoNoCurrent
41167-4246-4411674246041 BOTTLE in 1 CARTON (41167-4246-4) / 120 mL in 1 BOTTLE1 bottle2023-03-01NoNoCurrent