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 35 of 45 · 882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Wal-Zyr DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company778ba62e-6cce-4d0f-b6d9-48b35ef40da72024-01-25WarningsExact identifier
unii: 64O047KTOA
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
unii: 64O047KTOA
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsExact identifier
unii: 64O047KTOA
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Allergy Relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS PHARMACY54a158e3-f545-4a01-bf8d-e72a286d734c2024-01-12WarningsExact identifier
unii: 64O047KTOA
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDESDA Laboratories, Inc.222a7e77-33a6-44ca-9ab1-0bc4fc431aa32024-01-11WarningsExact identifier
unii: 64O047KTOA
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: PDC6A3C0OX
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDETWIN MED, LLCd9437d88-da59-5567-e053-2995a90a362b2024-01-03WarningsExact identifier
unii: 64O047KTOA
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDEYYBA CORP0502f197-21e1-44f2-b621-c8df1ccd956e2024-01-03WarningsExact identifier
unii: 64O047KTOA
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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