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 26 of 51 · 1,014 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.06b61e15-ab8b-4b7e-8378-48f87a963e442025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.678874d0-7600-4d03-ad1e-e4dc671575972025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC365cbabe-535b-4c34-852b-6cd63782e3e52025-05-01Adverse reactionsExact identifier
unii: 64O047KTOA
Leader Childrens all day allergyCETIRIZINE HCLCardinal Health 110, LLC. dba Leader6e69ba49-a487-445b-b5f3-5e468d86ac442025-04-30WarningsExact identifier
unii: 64O047KTOA
Equaline childrens all day allergyCETIRIZINE HCLUnited Natural Foods, Inc. dba UNFIedd4240d-f719-4336-88fe-0960cd8006e02025-04-30WarningsExact identifier
unii: 64O047KTOA
TopCare Childrens All Day AllergyCETIRIZINE HCLTopco Associates LLC48555c1f-8c2a-4ab2-9af3-d2488ca509e42025-04-29WarningsExact identifier
unii: 64O047KTOA
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company5cdd59a0-4d23-4f51-9aca-d66a639f84722025-04-29WarningsExact identifier
unii: 64O047KTOA
Childrens All Day AllergyCETIRIZINE HCLKroger Company9526b509-40fb-4bab-b7b5-13ab600b728a2025-04-29WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLWALMART INC. (see also Equate)41bc1339-7137-4472-b47b-a7a36e24a9bb2025-04-29WarningsExact identifier
unii: 64O047KTOA
basic care childrens all day allergyCETIRIZINE HCLAmazon.com Services LLCe32a86d9-e992-4212-b503-dcda524672a22025-04-29WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEINNOVUS PHARMACEUTICALS, INC.89db2c96-62f6-4e75-8f0d-321b44094c602025-04-28WarningsExact identifier
unii: 64O047KTOA
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company2a62f905-663f-4aae-991f-a368b5120f6f2025-04-24WarningsExact identifier
unii: 64O047KTOA
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HClCETIRIZINEGERI-CARE PHARMACEUTICAL CORP3389e947-b7d1-6caf-e063-6294a90a22382025-04-24WarningsExact identifier
unii: 64O047KTOA
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCa1edc2e6-3661-4d7a-884c-709d73cb89e02025-04-22WarningsExact identifier
unii: 64O047KTOA
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC6a962a1c-c197-492b-bfa6-e0c28eda15332025-04-11WarningsExact identifier
unii: 64O047KTOA
Bestmade Natural Products BM133 PelletsSILICEA, CARBO VEG, AURUM MUR, THUJA OCC, ACID NIT, FERRUM IODBestmade Natural Products3242a579-23f3-0063-e063-6394a90a93342025-04-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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