Childrens Allergy Relief

Product NDC
58602-422
11-digit product format
586020422
Labeler code
58602
Product ID
58602-422_91498d0f-2f98-4820-9db1-5b1815594ed6
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
2027-12-31
Current FDA listing
Yes

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

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)

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-422-12Childrens Allergy Relief1 in 1 CARTONSOLUTION17
58602-422-12Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1207
58602-422-17Childrens Allergy Relief480 mL in 1 BOTTLESOLUTION4807
58602-422-20Childrens Allergy Relief240 mL in 1 BOTTLESOLUTION2407
58602-422-20Childrens Allergy Relief1 in 1 CARTONSOLUTION17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-422CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]5Current NDC, Legacy NDC, 5 package rows20221104_52dc28ac-4059-4b6c-8bbc-22aa479a549a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN52dc28ac-4059-4b6c-8bbc-22aa479a549a7
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD52dc28ac-4059-4b6c-8bbc-22aa479a549a7
1014673cetirizine HCl 1 MG/ML Oral SyrupSY52dc28ac-4059-4b6c-8bbc-22aa479a549a7
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY52dc28ac-4059-4b6c-8bbc-22aa479a549a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-422-12586020422121 BOTTLE in 1 CARTON (58602-422-12) / 120 mL in 1 BOTTLE1 bottle2010-02-020000-00-00NoNoCurrent
58602-422-1758602042217480 mL in 1 BOTTLE (58602-422-17) 480 ml2010-02-02NoNoCurrent
58602-422-20586020422201 BOTTLE in 1 CARTON (58602-422-20) / 240 mL in 1 BOTTLE1 bottle2010-02-020000-00-00NoNoCurrent