FDA.reportPublic FDA data

NDC 49035-652-25 - Cetirizine Hydrochloride

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
49035-652
Requested NDC
49035-652-25
Package NDCs from labels
49035-652-25, 49035-652-24
Manufacturer
Wal-Mart Stores, Inc. | Novel Laboratories, Inc.
Effective date
2018-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Equate Cetirizine Hydrochloride Chewable Tablets 10 mgWal-Mart Stores, Inc. | Novel Laboratories, Inc.2018-12-21HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-652-242020-01-31C16284748780-19d75b9d0-c3eb-f424-e053-dadaa90a57ceEquate Cetirizine Hydrochloride Chewable Tablets 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-652-24Cetirizine Hydrochloride4 in 1 CARTONTABLET, CHEWABLE41
49035-652-25Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-652CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [WAL-MART STORES, INC.]1Legacy NDC, 2 package rows20181222_fcc77bdc-5fcc-43c1-be0d-1827eebccf35.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-652-24EA - Each49035-65265fae259-1451-42f2-94e2-ad1447fdb8cd12024-01-04

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 25 of 51 · 1,014 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens 24 Hour AllergyCETIRIZINE HCLMeijer Distribution Inc6a5549b3-e0a9-40e1-b80d-b81b2f1932c92025-06-25WarningsExact identifier
unii: 64O047KTOA
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEMorning Star OTC3efa421d-ea70-4b1f-95d0-7c63b6c395802025-06-19WarningsExact identifier
unii: 64O047KTOA
12 hour allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Incb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e772025-06-19WarningsExact identifier
unii: 64O047KTOA
ZYRTEC HivesCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31136e3a-94fa-0860-e063-6394a90a008d2025-06-16WarningsExact identifier
unii: 64O047KTOA
ZYRTEC HIVESCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31400cb2-fe85-ef74-e063-6294a90a11fb2025-06-16WarningsExact identifier
unii: 64O047KTOA
careone childrens allergy reliefCETIRIZINE HCLAmerican Sales Company0582736b-e129-4048-967c-6270c776f9db2025-06-12WarningsExact identifier
unii: 64O047KTOA
ZYRTEC-D Allergy Plus CongestionCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC1e8eb279-3522-40e4-8062-06b5354f0d292025-06-12WarningsExact identifier
unii: 64O047KTOA
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLNUVICARE LLC09dfdce2-7184-4247-983c-a5667e4a9da12025-06-09WarningsExact identifier
unii: 64O047KTOA
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
ALLERGY RELIEFCETIRIZINE HCLPioneer Life Sciences, LLC110adf3c-84ce-48a1-8a22-89ee3eec22d92025-06-01WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride 10 mgCETIRIZINE HYDROCHLORIDE 10 MGContract Pharmacal Corp.84459f11-3405-4a8e-be38-333b7de2a5782025-05-28WarningsExact identifier
unii: 64O047KTOA
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.5e37c522-a821-4673-9220-b59c739574452025-05-27WarningsExact identifier
unii: ETJ7Z6XBU4
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsExact identifier
unii: 64O047KTOA
Sinus TonicECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACIDBioActive Nutritional, Inc.63234fdc-7456-42c6-8996-fef372dd4a532025-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.ddfad5cd-c928-42c0-9562-9feebb73a2cb2025-05-19WarningsExact identifier
unii: ETJ7Z6XBU4
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLC7dabf6bd-8a96-4e7f-bc19-5a47cec364192025-05-16WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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