FDA.reportPublic FDA data

NDC 80425-0352-01 - Loratadine

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
80425-0352
Requested NDC
80425-0352-01
Package NDCs from labels
80425-0352-1, 80425-0352-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0352-1Loratadine30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0352LORATADINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_01cb43cf-57a9-f189-e063-6294a90afd88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0352-1EA - Each80425-0352f9390c79-9ee4-4e64-97a1-db6be06a732812023-09-05

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 9 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEA-S Medication Solutions4cee60b6-b32b-47d0-aa00-a7ea1a7ed3cf2025-11-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEWinCo Foods, LLC3dea627d-4b0c-e077-e063-6394a90a15a02025-11-03WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINEFamily Dollar (FAMILY WELLNESS)6b8d786e-2ee3-487f-bf7b-7dc738ea2fc92025-10-29WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
LoratadineLORATADINECabinet Health P.B.C.8b090fa2-9535-456c-b14d-187a2873cdf72025-10-27WarningsExact identifier
application number: ANDA214684
rxcui: 311372
unii: 7AJO3BO7QN
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
McKesson LoradatineLORATAINDEMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
CVS LoratadineLORATADINECVS Pharmacy3d716988-da63-59e6-e063-6394a90a5b4b2025-10-22WarningsExact identifier
application number: ANDA214684
rxcui: 311372
unii: 7AJO3BO7QN
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
equate loratadineLORATADINEWALMART INC.882dc99b-22d2-4f3e-8613-9ac8d9c5d9102025-10-14WarningsExact identifier
unii: 7AJO3BO7QN
Good Sense childrens allergy reliefLORATADINENuCare Pharmaceuticals,Inc.40d25cdf-b63f-d5c9-e063-6394a90af5092025-10-10WarningsExact identifier
unii: 7AJO3BO7QN
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED31cb3c06-7e15-4000-b169-50b66c14b01b2025-10-06WarningsExact identifier
unii: 7AJO3BO7QN
allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company512f8f46-5c62-470d-b14a-93b86ec34ce82025-10-03WarningsExact identifier
unii: 7AJO3BO7QN
First Aid Direct Allergy ReliefLORATADINE TABLETSCintas Corporation6b43e5a5-30a8-46ca-a44d-1e1abf567b512025-09-23WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
good neighbor pharmacy loratadine dLORATADINE, PSEUDOEPHEDRINE SULFATEAmerisource Bergen90b0a155-b92c-45e3-959f-8f21065d31dd2025-09-12WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMajor Pharmaceuticals2620a150-4a2c-4fa2-a0e4-6aafe9e496c32025-09-08WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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