FDA.reportPublic FDA data

ZYRTEC Allergy

Product NDC
50580-786
11-digit product format
505800786
Labeler code
50580
Product ID
50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA213105
Marketing category
ANDA
Marketing start
2024-04-15
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
ZYRTEC Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675, 1020023

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-786-12ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-12ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-13ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-13ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-40ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-40ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-41ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-41ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-65ZYRTEC Allergy65 in 1 PACKAGE, COMBINATIONCAPSULE, LIQUID FILLED656
50580-786-66ZYRTEC Allergy65 in 1 PACKAGECAPSULE, LIQUID FILLED656

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-786ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]4Current NDC, 14 package rows20250323_0face45c-af24-3559-e063-6294a90abde5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN0face45c-af24-3559-e063-6294a90abde56
1020023ZyrTEC 10 MG Oral CapsulePSN0face45c-af24-3559-e063-6294a90abde56
1020023cetirizine hydrochloride 10 MG Oral Capsule [Zyrtec]SBD0face45c-af24-3559-e063-6294a90abde56
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD0face45c-af24-3559-e063-6294a90abde56
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56
1020023Zyrtec (cetirizine dihydrochloride 10 MG) Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56
1020023Zyrtec 10 MG Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-786-12505800786121 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoHistorical
50580-786-13505800786131 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoHistorical
50580-786-25505800786251 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoHistorical
50580-786-26505800786261 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoHistorical
50580-786-40505800786401 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoHistorical
50580-786-41505800786411 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoHistorical
50580-786-655058007866565 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65) 2024-04-15NoNoHistorical
50580-786-665058007866665 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66) 2024-12-01NoNoHistorical