FDA.reportPublic FDA data

Childrens 24 Hour Allergy

Product NDC
41250-475
11-digit product format
412500475
Labeler code
41250
Product ID
41250-475_6b615779-697e-49e5-92f0-96be91b549b8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA204226
Marketing category
ANDA
Marketing start
2015-12-02
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens 24 Hour Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-475-00Childrens 24 Hour Allergy1 in 1 CARTONSOLUTION110
41250-475-00Childrens 24 Hour Allergy120 mL in 1 BOTTLESOLUTION12010
41250-475-26Childrens 24 Hour Allergy118 mL in 1 BOTTLESOLUTION11810
41250-475-26Childrens 24 Hour Allergy1 in 1 CARTONSOLUTION110
41250-475-34Childrens 24 Hour Allergy1 in 1 CARTONSOLUTION110
41250-475-34Childrens 24 Hour Allergy236 mL in 1 BOTTLESOLUTION23610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-475-26ML - Milliliter41250-475029e886c-324d-4cef-b98d-52075dce0b8612023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-475CHILDRENS 24 HOUR ALLERGY (CETIRIZINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]9Current NDC, Legacy NDC, 6 package rows20250430_6a5549b3-e0a9-40e1-b80d-b81b2f1932c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6a5549b3-e0a9-40e1-b80d-b81b2f1932c910
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6a5549b3-e0a9-40e1-b80d-b81b2f1932c910
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6a5549b3-e0a9-40e1-b80d-b81b2f1932c910
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6a5549b3-e0a9-40e1-b80d-b81b2f1932c910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-475-00412500475001 BOTTLE in 1 CARTON (41250-475-00) / 120 mL in 1 BOTTLE1 bottle2025-06-10NoNoCurrent
41250-475-26412500475261 BOTTLE in 1 CARTON (41250-475-26) / 118 mL in 1 BOTTLE1 bottle2015-12-020000-00-00NoNoCurrent
41250-475-34412500475341 BOTTLE in 1 CARTON (41250-475-34) / 236 mL in 1 BOTTLE1 bottle2015-12-020000-00-00NoNoCurrent