Childrens Cetirizine Hydrochloride Hives Relief

Product NDC
58602-030
11-digit product format
586020030
Labeler code
58602
Product ID
58602-030_95f01d24-5f39-41e2-b6d9-90c4f3fbdffe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA090750
Marketing category
ANDA
Marketing start
2015-06-24
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
2026-12-31
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 Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d2025-12-09WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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. hives that are an unusual color, look bruised or blistered hives that do not itch 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks 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 Cetirizine Hydrochloride Hives Relief
Listing expiration
2026-12-31

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
58602-030-20Childrens Cetirizine Hydrochloride Hives Relief240 mL in 1 BOTTLESOLUTION2405
58602-030-20Childrens Cetirizine Hydrochloride Hives Relief1 in 1 CARTONSOLUTION15
58602-030-24Childrens Cetirizine Hydrochloride Hives Relief1 in 1 CARTONSOLUTION15
58602-030-24Childrens Cetirizine Hydrochloride Hives Relief120 mL in 1 BOTTLESOLUTION1205
58602-030-26Childrens Cetirizine Hydrochloride Hives Relief480 mL in 1 BOTTLESOLUTION4805

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-030CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]4Current NDC, Legacy NDC, 5 package rows20221104_e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d5
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d5
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d5
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-030-20586020030201 BOTTLE in 1 CARTON (58602-030-20) / 240 mL in 1 BOTTLE1 bottle2015-06-240000-00-00NoNoCurrent
58602-030-24586020030241 BOTTLE in 1 CARTON (58602-030-24) / 120 mL in 1 BOTTLE1 bottle2015-06-240000-00-00NoNoCurrent
58602-030-2658602003026480 mL in 1 BOTTLE (58602-030-26) 480 ml2015-06-240000-00-00NoNoCurrent