NDC 50580-730

Childrens Zyrtec

Cetirizine Hydrochloride

Childrens Zyrtec is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Cetirizine Hydrochloride.

Product ID50580-730_522ea6d6-d308-4f37-9f85-539bb58c9a58
NDC50580-730
Product TypeHuman Otc Drug
Proprietary NameChildrens Zyrtec
Generic NameCetirizine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA022155
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-730-01

1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) > 30 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2017-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-730-15 [50580073015]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-06-01
Marketing End Date2015-05-29

NDC 50580-730-06 [50580073006]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-31

NDC 50580-730-09 [50580073009]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-06-01
Marketing End Date2015-05-29

NDC 50580-730-18 [50580073018]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-03

NDC 50580-730-05 [50580073005]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-07-13

NDC 50580-730-04 [50580073004]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-06-01
Marketing End Date2015-05-29

NDC 50580-730-17 [50580073017]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-03

NDC 50580-730-01 [50580073001]

Childrens Zyrtec SYRUP
Marketing CategoryNDA
Application NumberNDA022155
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-01-16

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:9d8e78ea-af98-4f7c-8db5-044b49582f80
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020021
  • 1014673

    • NDC Crossover Matching brand name "Childrens Zyrtec" or generic name "Cetirizine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-730Childrens ZyrtecChildrens Zyrtec
    0363-4101allergy reliefCetirizine Hydrochloride
    0113-7002Basic Care All Day AllergyCetirizine Hydrochloride
    0113-7036BASIC CARE ALL DAY ALLERGYCetirizine hydrochloride
    0121-4780Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8301Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8302Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-0471Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-9899Cetirizine HydrochlorideCetirizine Hydrochloride
    0378-3635Cetirizine Hydrochloridecetirizine hydrochloride
    0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride
    0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride
    0363-3311childrens allergy reliefCetirizine Hydrochloride
    0363-3393childrens allergy reliefCetirizine Hydrochloride
    0363-4025Childrens Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-1884childrens dye free wal zyrcetirizine Hydrochloride
    0363-0595Childrens Wal Zyr 24 Hour Allergycetirizine Hydrochloride
    0363-0974Childrens Wal Zyr Allergycetirizine hydrochloride
    0363-1974dye free wal zyrcetirizine hydrochloride
    0113-0981Good Sense All Day Allergycetirizine hydrochloride
    0113-1036good sense all day allergyCetirizine hydrochloride
    0113-9458Good Sense all day allergyCetirizine Hydrochloride
    0363-0276wal zyrCetirizine Hydrochloride
    0363-0495Wal ZyrCetirizine Hydrochloride
    0363-2088Wal-ZyrCetirizine Hydrochloride
    0363-2102Wal-ZyrCetirizine Hydrochloride
    0363-2106Wal-ZyrCetirizine Hydrochloride
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