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 49 of 50 · 986 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f5eb545f-57f8-42f5-b9d9-ee3b14661444fcc77bdc-5fcc-43c1-be0d-1827eebccf352018-12-21WarningsExact identifier
spl id: f5eb545f-57f8-42f5-b9d9-ee3b14661444
spl set id: fcc77bdc-5fcc-43c1-be0d-1827eebccf35
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECHAIN DRUG CONSORTIUM,LLC0f5de86d-1c87-4664-83f6-4c17f78f7d352018-11-30WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC9d7d2342-a594-4851-810b-b7bce1bd07dc2018-08-24WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEValu Merchandisers Company4a8d2887-8ac3-4d54-9e67-4a271d4164262018-08-23WarningsExact identifier
unii: 64O047KTOA
Quality Choice Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Marketing Association Inc.2e8cc4e3-8386-42de-801f-fef37f6128492018-08-22WarningsExact identifier
unii: 64O047KTOA
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarc Glassman, Inc.f30900e6-425f-43e0-81b6-1fa3bd321f0b2018-06-20WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDEH E Bfdd3f9a0-b4be-498a-b8e0-1a97403997362018-05-09WarningsExact identifier
unii: 64O047KTOA
Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Inc0d026538-5708-4030-b65d-18790e72059a2018-02-14WarningsExact identifier
unii: 64O047KTOA
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US, LLCa210d6b7-0829-4120-bb6d-fee0c2e57b262018-01-09WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEFAMILY DOLLAR SERVICES, INCb326dacc-6123-47a7-9fde-6909db1d780b2018-01-08WarningsExact identifier
unii: 64O047KTOA
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens CetirzineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLC6b22f568-7ebd-4479-b764-6e5481d8c15a2017-06-12WarningsExact identifier
unii: 64O047KTOA
ParathyroplexPARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEABioActive Nutritional, Inc.37649bb9-cbd7-4971-b410-18ea307c46f62017-04-18WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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