Childrens Allergy Relief

Product NDC
58602-424
11-digit product format
586020424
Labeler code
58602
Product ID
58602-424_d9672ecf-66fe-4ce6-b4ca-9953a7f63a24
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
Marketing end
0000-00-00
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
2023-12-31
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 productproduct58602-424DDiscontinued by firm2026-07-31
excluded packagepackage58602-42458602-424-24DDiscontinued 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)

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-424-24586020424241 BOTTLE in 1 CARTON (58602-424-24) > 120 mL in 1 BOTTLE1 bottle2010-02-020000-00-00NoNoCurrent