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 10 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy reliefLORATADINEPreferred Pharmaceuticals Inc.836f566c-0296-408a-ad2a-6a77e18552182025-08-29WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Wal-itinLORATADINEWalgreens6afa8056-1b7a-48a4-960c-92927169977e2025-08-28WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINEH E Bd710b760-794e-490b-a413-c7b2ee5149b92025-08-14WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESTRATEGIC SOURCING SERVICES LLC809456dc-1d1c-42a7-b17f-e43dacde927f2025-07-30WarningsExact identifier
unii: 7AJO3BO7QN
Allergy reliefLORATADINEGeri-Care Pharmaceutical Corpb66f171a-7b95-b27a-e053-2a95a90a60092025-07-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMylan Institutional Inc.1fc9ddd1-393d-4fe2-a9e0-d192df7331db2025-07-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINESTRATEGIC SOURCING SERVICES LLC6ba7fc5d-81c4-482c-8b38-4a6587853a9f2025-07-21WarningsExact identifier
unii: 7AJO3BO7QN
equate allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATEWal-Mart Stores Inc306e8736-b27f-4445-b613-3e5b609f8d422025-07-17WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEOhm Laboratories Inc.bbe83464-a582-469f-8fac-f98e804d96fe2025-07-15WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergyLORATADINEPublix Super Markets Incfa429380-019e-4ccd-8444-d5d931c4cc652025-07-15WarningsExact identifier
unii: 7AJO3BO7QN
Nuvicare-Allergy Relief Loratadine Tablets, 10 mgLORATADINENUVICARE LLC023a46f0-8d1c-4f62-953d-3e6458a54f6e2025-07-01WarningsExact identifier
application number: ANDA214684
rxcui: 311372
unii: 7AJO3BO7QN
Gencare-Allergy Relief Loratadine Tablets, 10 mgLORATADINEPioneer Life Sciences, LLC647dc957-4aee-48f6-bb77-e82d3b380e802025-06-30WarningsExact identifier
application number: ANDA214684
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINELannett Company, Inc.069c4e75-1f9f-4ab5-9570-3d93d12c2a232025-06-19WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBryant Ranch Prepackbaad51cd-daa0-4920-a6d5-2faaaaea79562025-06-18WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Curist Allergy ReliefLORATADINE 10 MGLittle Pharma, Inc.0c53cf0f-7682-a422-e063-6394a90ab7642025-06-15WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEBryant Ranch Prepack0d74af21-3ef7-418b-a2ef-78737b0af2882025-06-13WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
foster and thrive allergy D 12 hourLORATADINE, PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLC4626e3ca-d3e9-46ad-9c53-66d27c82aed72025-06-13WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBryant Ranch Prepacka5d54183-06a9-4ae1-93b9-e9a2e03ad42b2025-06-13WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
365 Whole Foods Market LoratadineLORATADINEWhole Foods Market, Inc.bba4e7c8-db8e-4522-915c-48ee809e3bce2025-06-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEMeijer Distribution Incdd19215c-0da7-483a-88e3-6a32ac210c4c2025-05-28WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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