FDA.reportPublic FDA data

NDC 59368-449 - Cetirizine HCl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59368-449
Package NDCs from labels
59368-449-03, 59368-449-04, 59368-449-01, 59368-449-02
Manufacturer
Sixarp, LLC
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine HCl - Sixarp, LLCSixarp, LLC2026-05-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59368-449-01Cetirizine HCl80 in 1 BOTTLE, PLASTICCAPSULE801
59368-449-02Cetirizine HCl1 in 1 CARTONCAPSULE11
59368-449-03Cetirizine HCl40 in 1 BOTTLE, PLASTICCAPSULE401
59368-449-04Cetirizine HCl1 in 1 CARTONCAPSULE11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 32 of 45 · 882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.6eb22b5a-ff30-44f8-aca2-3f73614515a82024-08-16WarningsExact identifier
unii: 64O047KTOA
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-9001-8776-e053-2a95a90ae6512024-08-12WarningsExact identifier
unii: 64O047KTOA
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
childrens allergy reliefCETIRIZINE HYDROCHLORIDESafeway5d3e4c52-b697-4b91-af28-124f74d937e52024-08-02WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC214936a2-adc4-422a-a8fe-4c3ce9e01f362024-07-31WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC273172b2-9aaf-46fb-a1ce-2961650eacd32024-07-31WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack4b192084-dfdc-47bc-a968-6f49e137b2482024-07-25WarningsExact identifier
unii: 64O047KTOA
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail IntensiveGLYCERINMISOCOS97747267-26f1-d06f-e053-2a95a90ab0872024-07-04WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions42c9636f-07af-44a3-8d84-c11e1b57783a2024-07-02WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP4ed61888-4b22-4e11-96e7-f70aa516db4f2024-07-01Adverse reactionsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDENorthStar Rx LLCc9d1e26f-c95a-4991-95fa-9ed6ed484fe22024-06-26WarningsExact identifier
unii: 64O047KTOA
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsb53d5e8a-a30c-4025-aa72-d2776a112e3e2024-06-24WarningsExact identifier
unii: 64O047KTOA
SIMPLY RIGHT childrens cetirizineCETIRIZINE HYDROCHLORIDESam's West Inc48b47541-cf0c-48a7-9a65-2158fd1284f12024-06-24WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.