FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
58602-424
Requested package NDC
58602-424-24
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58602-42458602-424-24DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…
2026-08-01 22:54:322026-06A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLC52dc28ac-4059-4b6c-8bbc-22aa479a549a2026-03-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride AllergyCETIRIZINE HYDROCHLORIDEAurohealth LLC4de4f544-79cd-4a89-aafb-f2e2688b3c812026-03-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCbd489217-bf7c-429b-a58c-426104f7e7792025-12-16WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d2025-12-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEFred's, Inc.55e799b2-e325-4286-aa9a-b88e99ab11462020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEC.D.M.A., Inc.b4feed95-86ca-411c-99b5-773e485e752f2020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750

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