Childrens Cetirizine Hydrochloride Hives Relief

Product NDC
58602-036
11-digit product format
586020036
Labeler code
58602
Product ID
58602-036_bd489217-bf7c-429b-a58c-426104f7e779
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA090750
Marketing category
ANDA
Marketing start
2010-02-02
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
64O047KTOACETIRIZINE HYDROCHLORIDE83881-52-1CETIRIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-036-15586020036151 BOTTLE in 1 CARTON (58602-036-15) / 120 mL in 1 BOTTLE1 bottle2010-02-02NoNoHistorical
58602-036-16586020036161 BOTTLE in 1 CARTON (58602-036-16) / 240 mL in 1 BOTTLE1 bottle2010-02-02NoNoHistorical
58602-036-1758602003617480 mL in 1 BOTTLE (58602-036-17) 480 ml2010-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cetirizine Hydrochloride - Aurohealth LLC | Aurobindo Pharma LimitedAurohealth LLC | Aurobindo Pharma Limited2025-12-16Human OTC Drug Label1