Leader Childrens all day allergy

Product NDC
70000-0215
11-digit product format
700000215
Labeler code
70000
Product ID
70000-0215_4adfb8b5-ab2e-42de-beda-76bc865afadd
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
2017-02-10
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
70000-0215-1Leader Childrens all day allergy118 mL in 1 BOTTLESOLUTION1184
70000-0215-1Leader Childrens all day allergy1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0215-1ML - Milliliter70000-0215ec64b796-acc9-4bf1-8857-f969cf3eb0b012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0215LEADER CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20250501_6e69ba49-a487-445b-b5f3-5e468d86ac44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6e69ba49-a487-445b-b5f3-5e468d86ac444
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6e69ba49-a487-445b-b5f3-5e468d86ac444
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6e69ba49-a487-445b-b5f3-5e468d86ac444
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6e69ba49-a487-445b-b5f3-5e468d86ac444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0215-1700000215011 BOTTLE in 1 CARTON (70000-0215-1) / 118 mL in 1 BOTTLE1 bottle2017-02-100000-00-00NoNoCurrent