Cetirizine Hydrochloride (Hives Relief)

Product NDC
58602-447
11-digit product format
586020447
Labeler code
58602
Product ID
58602-447_5ebdf17c-288b-4fed-89c8-7d1f42a128d0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride (Hives Relief)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014676, 1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-447-09Cetirizine Hydrochloride (Hives Relief)30 in 1 BOTTLETABLET306
58602-447-09Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONTABLET16
58602-447-17Cetirizine Hydrochloride (Hives Relief)45 in 1 BOTTLETABLET456
58602-447-17Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONTABLET16
58602-447-21Cetirizine Hydrochloride (Hives Relief)10 in 1 CARTONTABLET106
58602-447-21Cetirizine Hydrochloride (Hives Relief)10 in 1 BLISTER PACKTABLET106
58602-447-41Cetirizine Hydrochloride (Hives Relief)1000 in 1 BOTTLETABLET10006
58602-447-47Cetirizine Hydrochloride (Hives Relief)75 in 1 PACKAGE, COMBINATIONTABLET756

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-447CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]6Current NDC, Legacy NDC, 8 package rows20250214_2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014676cetirizine HCl 5 MG Oral TabletPSN2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014676cetirizine hydrochloride 5 MG Oral TabletSCD2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014678cetirizine HCl 10 MG Oral TabletSY2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-447-09586020447091 BOTTLE in 1 CARTON (58602-447-09) / 30 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-447-17586020447171 BOTTLE in 1 CARTON (58602-447-17) / 45 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-447-215860204472110 BLISTER PACK in 1 CARTON (58602-447-21) / 10 TABLET in 1 BLISTER PACK10 blister pack2015-08-050000-00-00NoNoCurrent
58602-447-41586020447411000 TABLET in 1 BOTTLE (58602-447-41) 1000 tablet2015-08-050000-00-00NoNoCurrent
58602-447-475860204474775 TABLET in 1 PACKAGE, COMBINATION (58602-447-47) 75 tablet2015-08-050000-00-00NoNoCurrent