Leader Childrens All Day Allergy

Product NDC
70000-0214
11-digit product format
700000214
Labeler code
70000
Product ID
70000-0214_9f319209-117d-4696-b132-2b99e4c75cd7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA204226
Marketing category
ANDA
Marketing start
2017-02-28
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
Leader Childrens All Day 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
70000-0214-1Leader Childrens All Day Allergy118 mL in 1 BOTTLESOLUTION1184
70000-0214-1Leader Childrens All Day Allergy1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0214-1ML - Milliliter70000-0214bae59ab5-9401-4ce1-aad3-b553fdddd9fb12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0214LEADER CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20210618_b11080bf-5916-497d-966a-eb13191a6b87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNb11080bf-5916-497d-966a-eb13191a6b874
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDb11080bf-5916-497d-966a-eb13191a6b874
1014673cetirizine HCl 1 MG/ML Oral SyrupSYb11080bf-5916-497d-966a-eb13191a6b874
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYb11080bf-5916-497d-966a-eb13191a6b874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0214-1700000214011 BOTTLE in 1 CARTON (70000-0214-1) / 118 mL in 1 BOTTLE1 bottle2017-02-280000-00-00NoNoCurrent