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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SOD6A38AGALEVOCETIRIZINE DIHYDROCHLORIDE130018-87-0LEVOCETIRIZINE DIHYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-3511-2411673511021 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK1 blister pack2023-09-01NoNoHistorical
41167-3511-8411673511081 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK1 blister pack2026-01-01NoNoHistorical
41167-3511-9411673511091 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK1 blister pack2026-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Xyzal Allergy 24HRChattem, Inc.2026-03-11HUMAN OTC DRUG LABEL14