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 2 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
unii: 64O047KTOA
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsExact identifier
unii: 64O047KTOA
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
unii: 64O047KTOA
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsExact identifier
unii: 64O047KTOA
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
QUZYTTIRCETIRIZINE HYDROCHLORIDEESTEVE PHARMACEUTICALS, S.A.573770f6-b76e-f6ba-e063-6294a90aa54d2026-08-13Warnings, Adverse reactionsExact identifier
unii: 64O047KTOA
allergy relief childrensCETIRIZINE HCLCVS Pharmacy1a20acb5-207f-4499-a4c3-8733454555382026-08-13WarningsExact identifier
unii: 64O047KTOA
Childrens Allergy ReliefCETIRIZINE HCLCVS Pharmacy0210f9e5-c35b-4cfa-92d1-48555e99f1f32026-08-13WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLC29bac87e-8559-47be-838d-c00e57f9f7ba2026-08-12WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINEGLENMARK THERAPEUTICS INC., USA04b08c52-5390-4cdb-a9e7-fca81fffdc732026-08-07WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
unii: 64O047KTOA
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
unii: 64O047KTOA
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 64O047KTOA
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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