FDA.reportPublic FDA data

NDC 59368-449-01 - 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
Requested NDC
59368-449-01
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 40 of 44 · 871 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens cetirizine hydrochlorideCETIRIZINE HCLProficient Rx LP8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e2022-11-01WarningsExact identifier
unii: 64O047KTOA
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
careone allergy reliefCETIRIZINE HYDROCHLORIDERetail Business Services, LLC6d94d302-b79a-4143-bb3c-c74da2a6a72e2022-10-20WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLCare One (Retail Business Services, LLC.)04a6087e-d854-4e70-9d89-3971890a44a32022-10-20WarningsExact identifier
unii: 64O047KTOA
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Welby Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAldi Inca8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a2022-10-13WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsExact identifier
unii: 64O047KTOA
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsExact identifier
unii: 64O047KTOA
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
Good Sense All Day AllergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company5b1203c7-9678-4cee-9d7b-6510da2955612022-09-08WarningsExact identifier
unii: 64O047KTOA
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC1bbefda2-d3c5-4d31-b3ec-7da077e411572022-08-16WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEStrategic Sourcing Services1dd63ede-37ca-4b5a-bfed-1aca5dd154242022-07-27WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDERITE AID CORPORATIONde169567-5cde-5c4a-e053-2a95a90a12152022-07-21WarningsExact identifier
unii: 64O047KTOA
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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