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 5 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINECVS Pharmacy0038bc38-c205-4d8d-ab78-1abbcd76829e2026-02-25WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINEKroger Company745d48f2-504d-4e3d-abf8-768d201cf8142026-02-24WarningsExact identifier
unii: 7AJO3BO7QN
Alavert AllergyLORATADINEFoundation Consumer Brandsf741d1cf-0ecb-4405-8596-07af394537db2026-02-23WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Berkley and Jensen Allergy ReliefLORATADINEBJWCe981a0ef-08e9-4ac3-92a1-411217e0a2512026-02-16WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticals60162446-4fa1-4ee3-ae20-19fadc2491ab2026-02-09WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESportpharm LLC2b432b67-f9f3-45e2-8306-2d4080152f992026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATESportpharm LLCbb54f613-b2ab-48fd-83c9-2038ec7097f62026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Childrens Loratadine OralLORATADINEAtlantic Biologicals4a1a6981-133c-d45b-e063-6294a90a4a092026-02-05WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEKroger Companydac0b200-6b02-4c8a-b1dd-a4d5341dfb2d2026-02-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
LoratadineLORATADINEStrategic Sourcing Services, LLCa527f83a-4ae9-47b1-94e0-7ab3148b025f2026-01-29WarningsExact identifier
application number: ANDA214684
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Childrens Loratadine Sugar FreeLORATADINEPreferred Pharmaceuticals Inc.23936948-71bf-4c18-9160-22b7075e675d2026-01-15WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINEWalgreen Company42a73448-104a-4c7f-aea0-cef44d15f5f12026-01-13WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEAdvagen Pharma Limiteda5699a95-c0a7-43ea-9bab-bbfaba3c8aa52026-01-05Exact identifier
unii: 7AJO3BO7QN
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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