Xyzal Allergy 24HR

Product NDC
41167-3513
11-digit product format
411673513
Labeler code
41167
Product ID
41167-3513_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA209089
Marketing category
NDA
Marketing start
2026-01-01
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
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
Xyzal Allergy 24HR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172, 855174

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-3513-4Xyzal Allergy 24HR90 in 1 BLISTER PACKTABLET9014
41167-3513-4Xyzal Allergy 24HR1 in 1 CARTONTABLET114

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8be45c2a-1eca-4a00-81b9-f7babdbdcd4114
855174Xyzal 5 MG 24HR Oral TabletPSN8be45c2a-1eca-4a00-81b9-f7babdbdcd4114
855174levocetirizine dihydrochloride 5 MG Oral Tablet [Xyzal]SBD8be45c2a-1eca-4a00-81b9-f7babdbdcd4114
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8be45c2a-1eca-4a00-81b9-f7babdbdcd4114
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8be45c2a-1eca-4a00-81b9-f7babdbdcd4114
855174Xyzal 5 MG 24 HR Oral TabletSY8be45c2a-1eca-4a00-81b9-f7babdbdcd4114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-3513-4411673513041 BLISTER PACK in 1 CARTON (41167-3513-4) / 90 TABLET in 1 BLISTER PACK1 blister pack2026-01-01NoNoCurrent