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 35 of 50 · 986 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP4ed61888-4b22-4e11-96e7-f70aa516db4f2024-07-01Adverse reactionsExact identifier
unii: 64O047KTOA
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsb53d5e8a-a30c-4025-aa72-d2776a112e3e2024-06-24WarningsExact identifier
unii: 64O047KTOA
SIMPLY RIGHT childrens cetirizineCETIRIZINE HYDROCHLORIDESam's West Inc48b47541-cf0c-48a7-9a65-2158fd1284f12024-06-24WarningsExact identifier
unii: 64O047KTOA
Zyrtec Allergy, Lil Drug StoreCETIRIZINE HYDROCHLORIDE TABLET, FILM COATEDLil' Drug Store Products, Inc.1b6c945f-591f-8869-e063-6294a90ad3972024-06-21WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma71448ab0-e23e-4cf7-940e-7d67e7362fb42024-06-19Adverse reactionsExact identifier
unii: 64O047KTOA
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDETOPCO ASSOCIATES LLCf4ba3e0c-e6b3-2596-e053-2a95a90ab8502024-06-11WarningsExact identifier
unii: 64O047KTOA
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a361030-a925-0998-e063-6394a90a915d2024-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
up and up childrens allergyCETIRIZINE HYDROCHLORIDETarget Corporation4b1ee9b1-d22e-4fb2-8dcd-912374da12d72024-06-06WarningsExact identifier
unii: 64O047KTOA
up and up childrens allergyCETIRIZINE HYDROCHLORIDETarget Corporation1f37c327-cd4c-4bc1-ae70-713569694e2e2024-06-04WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLStrategic Sourcing Services LLC9e996c4a-524e-4f93-8d46-ac289d8cdd672024-05-30WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLCb064f4ba-d5ff-c503-e053-2995a90ab1ec2024-05-21WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be72024-05-21WarningsExact identifier
unii: 64O047KTOA
Multiple MiasmACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.92c97bf6-8dd9-43a9-b686-75420b0291972024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVAEnergique, Inc.6c346a26-26a2-4be0-b8a3-bbb5709bcf3d2024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEOPMX LLCb452bca6-2c51-d0a1-e053-2995a90aff672024-05-17WarningsExact identifier
unii: 64O047KTOA
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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