FDA.reportPublic FDA data

Childrens Cetirizine Hydrochloride

Product NDC
58602-856
11-digit product format
586020856
Labeler code
58602
Product ID
58602-856_bc89802b-be9c-489d-b006-7dd0bb7e2ceb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA213557
Marketing category
ANDA
Marketing start
2020-09-11
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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 Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1011482

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
58602-856-14Childrens Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING64
58602-856-14Childrens Cetirizine Hydrochloride11 in 1 CARTONTABLET, ORALLY DISINTEGRATING114
58602-856-75Childrens Cetirizine Hydrochloride2 in 1 CARTONTABLET, ORALLY DISINTEGRATING24
58602-856-75Childrens Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING64
58602-856-76Childrens Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING64
58602-856-76Childrens Cetirizine Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-856CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC]3Current NDC, Legacy NDC, 6 package rows20250112_cd895177-3c25-4a1b-81a0-b85f4877787a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011482cetirizine HCl 10 MG Disintegrating Oral TabletPSNcd895177-3c25-4a1b-81a0-b85f4877787a4
1011482cetirizine hydrochloride 10 MG Disintegrating Oral TabletSCDcd895177-3c25-4a1b-81a0-b85f4877787a4
1011482cetirizine HCl 10 MG Disintegrating Oral TabletSYcd895177-3c25-4a1b-81a0-b85f4877787a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-856-145860208561411 BLISTER PACK in 1 CARTON (58602-856-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK11 blister pack2020-09-110000-00-00NoNoCurrent
58602-856-75586020856752 BLISTER PACK in 1 CARTON (58602-856-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2020-09-110000-00-00NoNoCurrent
58602-856-76586020856764 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2020-09-110000-00-00NoNoCurrent