FDA.reportPublic FDA data

Xyzal Allergy 24HR

Product NDC
41167-3510
11-digit product format
411673510
Labeler code
41167
Product ID
41167-3510_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
2017-03-10
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
41167-3510-0Xyzal Allergy 24HR10 in 1 BLISTER PACKTABLET1014
41167-3510-0Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-1Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-1Xyzal Allergy 24HR35 in 1 BOTTLETABLET3514
41167-3510-2Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-2Xyzal Allergy 24HR55 in 1 BOTTLETABLET5514
41167-3510-3Xyzal Allergy 24HR80 in 1 BOTTLETABLET8014
41167-3510-3Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-4Xyzal Allergy 24HR55 in 1 BOTTLETABLET5514
41167-3510-4Xyzal Allergy 24HR2 in 1 CARTONTABLET214
41167-3510-5Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-5Xyzal Allergy 24HR45 in 1 BOTTLETABLET4514
41167-3510-6Xyzal Allergy 24HR5 in 1 BLISTER PACKTABLET514
41167-3510-6Xyzal Allergy 24HR1 in 1 CARTONTABLET114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-3510-0EA - Each41167-3510ed422210-66a2-43a7-a74f-170d7fd559a312017-04-05
41167-3510-1EA - Each41167-3510c4714fa6-0acb-47c4-9e49-3b7987d1ffa812017-04-05
41167-3510-2EA - Each41167-3510a4d33942-1af5-49ae-b610-a78020abde8212017-04-05
41167-3510-3EA - Each41167-351012df48b0-057c-414c-b5cf-92d286777a4f12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-3510XYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [CHATTEM, INC.]11Current NDC, Legacy NDC, 14 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 startMarketing endSampleExclude flagStatus
41167-3510-0411673510001 BLISTER PACK in 1 CARTON (41167-3510-0) / 10 TABLET in 1 BLISTER PACK1 blister pack2017-03-100000-00-00NoNoCurrent
41167-3510-1411673510011 BOTTLE in 1 CARTON (41167-3510-1) / 35 TABLET in 1 BOTTLE1 bottle2017-03-100000-00-00NoNoCurrent
41167-3510-2411673510021 BOTTLE in 1 CARTON (41167-3510-2) / 55 TABLET in 1 BOTTLE1 bottle2017-03-100000-00-00NoNoCurrent
41167-3510-3411673510031 BOTTLE in 1 CARTON (41167-3510-3) / 80 TABLET in 1 BOTTLE1 bottle2017-03-100000-00-00NoNoCurrent
41167-3510-4411673510042 BOTTLE in 1 CARTON (41167-3510-4) / 55 TABLET in 1 BOTTLE2 bottle2017-03-100000-00-00NoNoCurrent
41167-3510-5411673510051 BOTTLE in 1 CARTON (41167-3510-5) / 45 TABLET in 1 BOTTLE1 bottle2024-01-04NoNoHistorical
41167-3510-6411673510061 BLISTER PACK in 1 CARTON (41167-3510-6) / 5 TABLET in 1 BLISTER PACK1 blister pack2018-11-15NoNoHistorical