FDA.reportPublic FDA data

childrens allergy

Product NDC
56062-102
11-digit product format
560620102
Labeler code
56062
Product ID
56062-102_39fcf979-486a-5810-e063-6394a90aaeac
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
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 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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-102-08childrens allergy120 mL in 1 BOTTLESOLUTION1204
56062-102-08childrens allergy1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-102CHILDRENS ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [PUBLIX SUPER MARKETS INC]3Current NDC, Legacy NDC, 2 package rows20241222_ae216d0b-8ccc-4cc4-82f4-4d0f3a256822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNae216d0b-8ccc-4cc4-82f4-4d0f3a2568224
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDae216d0b-8ccc-4cc4-82f4-4d0f3a2568224
1014673cetirizine HCl 1 MG/ML Oral SyrupSYae216d0b-8ccc-4cc4-82f4-4d0f3a2568224
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYae216d0b-8ccc-4cc4-82f4-4d0f3a2568224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-102-08560620102081 BOTTLE in 1 CARTON (56062-102-08) / 120 mL in 1 BOTTLE1 bottle2016-11-040000-00-00NoNoCurrent