FDA.reportPublic FDA data

Childrens Xyzal Allergy

Product NDC
41167-3533
11-digit product format
411673533
Labeler code
41167
Product ID
41167-3533_bf07d0c3-0342-4fcc-82e4-954ee3076de0
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA209090
Marketing category
NDA
Marketing start
2024-01-04
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
2.5 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 Xyzal Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE2.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855168, 855170

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-3533-0Childrens Xyzal Allergy148 mL in 1 BOTTLESOLUTION14822
41167-3533-0Childrens Xyzal Allergy1 in 1 CARTONSOLUTION122
41167-3533-1Childrens Xyzal Allergy295 mL in 1 BOTTLESOLUTION29522
41167-3533-1Childrens Xyzal Allergy1 in 1 CARTONSOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-3533-1ML - Milliliter41167-3533fd4586e3-f0d7-47f0-945d-e8d20b0609cc12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-3533CHILDRENS XYZAL ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) SOLUTION [CHATTEM, INC.]18Current NDC, 4 package rows20250228_a33f2704-d350-428b-b467-91f4775ce17f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855168levocetirizine dihydrochloride 2.5 MG in 5 mL Oral SolutionPSNa33f2704-d350-428b-b467-91f4775ce17f22
855170XYZAL 2.5 MG in 5 mL 24HR Oral SolutionPSNa33f2704-d350-428b-b467-91f4775ce17f22
855170levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [Xyzal]SBDa33f2704-d350-428b-b467-91f4775ce17f22
855168levocetirizine dihydrochloride 0.5 MG/ML Oral SolutionSCDa33f2704-d350-428b-b467-91f4775ce17f22
855168levocetirizine dihydrochloride 2.5 MG per 5 ML Oral SolutionSYa33f2704-d350-428b-b467-91f4775ce17f22
855170Xyzal 0.5 MG/ML Oral SolutionSYa33f2704-d350-428b-b467-91f4775ce17f22
855170Xyzal 2.5 MG per 5 ML 24 HR Oral SolutionSYa33f2704-d350-428b-b467-91f4775ce17f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-3533-0411673533001 BOTTLE in 1 CARTON (41167-3533-0) / 148 mL in 1 BOTTLE1 bottle2024-01-04NoNoCurrent
41167-3533-1411673533011 BOTTLE in 1 CARTON (41167-3533-1) / 295 mL in 1 BOTTLE1 bottle2026-01-01NoNoCurrent