FDA.reportPublic FDA data

Xyzal Allergy 24HR

Product NDC
41167-3511
11-digit product format
411673511
Labeler code
41167
Product ID
41167-3511_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
2023-09-01
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
41167-3511-2Xyzal Allergy 24HR20 in 1 BLISTER PACKTABLET2014
41167-3511-2Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-8Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-8Xyzal Allergy 24HR40 in 1 BLISTER PACKTABLET4014
41167-3511-9Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-9Xyzal Allergy 24HR60 in 1 BLISTER PACKTABLET6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-3511XYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [CHATTEM, INC.]11Current NDC, 6 package rows20250213_8be45c2a-1eca-4a00-81b9-f7babdbdcd41.zip

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
41167-3511-2411673511021 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK1 blister pack2023-09-01NoNoCurrent
41167-3511-8411673511081 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK1 blister pack2026-01-01NoNoCurrent
41167-3511-9411673511091 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK1 blister pack2026-01-01NoNoCurrent