FDA.reportPublic FDA data

Cetirizine Hydrochloride (Hives Relief)

Product NDC
58602-808
11-digit product format
586020808
Labeler code
58602
Product ID
58602-808_30494d65-a846-4f13-a076-242f193e4651
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA209107
Marketing category
ANDA
Marketing start
2018-07-20
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
Rxcui1014675

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
58602-808-04Cetirizine Hydrochloride (Hives Relief)12 in 1 BOTTLECAPSULE124
58602-808-04Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-12Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-12Cetirizine Hydrochloride (Hives Relief)40 in 1 BOTTLECAPSULE404
58602-808-16Cetirizine Hydrochloride (Hives Relief)65 in 1 BOTTLECAPSULE654
58602-808-16Cetirizine Hydrochloride (Hives Relief)65 in 1 CARTONCAPSULE654
58602-808-53Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-53Cetirizine Hydrochloride (Hives Relief)25 in 1 BOTTLECAPSULE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-808CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) (CETIRIZINE HYDROCHLORIDE) CAPSULE [AUROHEALTH LLC]4Current NDC, Legacy NDC, 8 package rows20200915_f0f486e1-2eeb-4eaa-b557-908bcbf973a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNf0f486e1-2eeb-4eaa-b557-908bcbf973a84
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDf0f486e1-2eeb-4eaa-b557-908bcbf973a84
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYf0f486e1-2eeb-4eaa-b557-908bcbf973a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-808-04586020808041 BOTTLE in 1 CARTON (58602-808-04) / 12 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent
58602-808-12586020808121 BOTTLE in 1 CARTON (58602-808-12) / 40 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent
58602-808-165860208081665 BOTTLE in 1 CARTON (58602-808-16) / 65 CAPSULE in 1 BOTTLE65 bottle2018-07-200000-00-00NoNoCurrent
58602-808-53586020808531 BOTTLE in 1 CARTON (58602-808-53) / 25 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent