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 43 of 50 · 986 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILICEASILICON DIOXIDEHyland's Inc.86da31ff-b39a-4ac2-92e5-810f6d8888e62022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEHyland's Inc.d3c426ab-1a61-3494-e053-2a95a90a96772022-12-14WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICEAHahnemann Laboratories, INC.efcdc393-5dab-38d1-e053-2995a90acb2e2022-12-14Exact identifier
unii: ETJ7Z6XBU4
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCed8951a1-bd7e-439d-a427-685d56a9c9ad2022-11-07WarningsExact identifier
unii: 64O047KTOA
childrens cetirizine hydrochlorideCETIRIZINE HCLProficient Rx LP8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e2022-11-01WarningsExact identifier
unii: 64O047KTOA
careone allergy reliefCETIRIZINE HYDROCHLORIDERetail Business Services, LLC6d94d302-b79a-4143-bb3c-c74da2a6a72e2022-10-20WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLCare One (Retail Business Services, LLC.)04a6087e-d854-4e70-9d89-3971890a44a32022-10-20WarningsExact identifier
unii: 64O047KTOA
Welby Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAldi Inca8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a2022-10-13WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsExact identifier
unii: 64O047KTOA
Good Sense All Day AllergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company5b1203c7-9678-4cee-9d7b-6510da2955612022-09-08WarningsExact identifier
unii: 64O047KTOA
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC1bbefda2-d3c5-4d31-b3ec-7da077e411572022-08-16WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEStrategic Sourcing Services1dd63ede-37ca-4b5a-bfed-1aca5dd154242022-07-27WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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