FDA.reportPublic FDA data

Childrens Cetirizine Hydrochloride Hives Relief

Product NDC
65862-443
11-digit product format
658620443
Labeler code
65862
Product ID
65862-443_2474de7e-aff1-473e-9adf-8ec07b5a3dc1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090750
Marketing category
ANDA
Marketing start
2010-02-02
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65862-443DDiscontinued by firm2026-07-31
excluded packagepackage65862-44365862-443-12DDiscontinued by firm2026-07-31
excluded packagepackage65862-44365862-443-24DDiscontinued by firm2026-07-31
excluded packagepackage65862-44365862-443-48DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02
A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLC52dc28ac-4059-4b6c-8bbc-22aa479a549a2026-03-09WarningsExact identifier
Childrens Cetirizine Hydrochloride AllergyCETIRIZINE HYDROCHLORIDEAurohealth LLC4de4f544-79cd-4a89-aafb-f2e2688b3c812026-03-09WarningsExact identifier
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCbd489217-bf7c-429b-a58c-426104f7e7792025-12-16WarningsExact identifier
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d2025-12-09WarningsExact identifier
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEFred's, Inc.55e799b2-e325-4286-aa9a-b88e99ab11462020-12-13WarningsExact identifier
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEC.D.M.A., Inc.b4feed95-86ca-411c-99b5-773e485e752f2020-12-13WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
CETIRIZINEACTIVE MOIETYYO7261ME24CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]2