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 31 of 50 · 986 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
NO-WEAK-NAILSGRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDEMiers Laboratories9158cd3f-4c27-40e9-bc07-fd560375c3a12025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
good neighbor pharmacy all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergena7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b2025-01-03WarningsExact identifier
unii: 64O047KTOA
Good Neighbor Pharmacy Childrens All Day AllergyCETIRIZINE HCLAmerisource Bergenc6951587-fe03-4bc8-8f0c-0687d49f71592025-01-03WarningsExact identifier
unii: 64O047KTOA
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERITE AID1bf7c028-1648-4211-8847-84cce833a0f12025-01-02WarningsExact identifier
unii: 64O047KTOA
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NeuropathEaseAGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEASilver Star Brands7809e54a-018d-9cf6-e053-2a91aa0aedfe2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
CABINET Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCe49c3c91-aab8-478e-97fa-04ed061800212024-12-30WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLC507df969-804c-4e95-bb42-c1224fce2b282024-12-30WarningsExact identifier
unii: 64O047KTOA
Rite Aid childrens allergy reliefCETIRIZINE HYDROCHLORIDERite Aid Corporationedbefbee-26b6-46bc-abcc-f7b2817705e52024-12-19WarningsExact identifier
unii: 64O047KTOA
Childrens AllergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Inc9a8b5af0-72bb-48d5-bb5e-0dc6808bf4662024-12-19WarningsExact identifier
unii: 64O047KTOA
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c24f3760-70e0-410f-bf80-6d0cadcd61b92024-12-16WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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