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 11 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief-DLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB36230417-8687-d9fd-e063-6394a90ac2e52025-05-27WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEAsclemed USA, Inc.332bda00-1350-2d33-e063-6394a90a8bd72025-05-21WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINE ORALBluePoint Laboratoriesab820f80-b5fc-7896-e053-2995a90a4b1c2025-05-15WarningsExact identifier
unii: 7AJO3BO7QN
Children Claritin AllergyLORATADINEBayer HealthCare LLC.170061e9-e529-4ff0-e054-00144ff8d46c2025-05-15WarningsExact identifier
unii: 7AJO3BO7QN
basic care childrens allergy reliefLORATADINEAmazon.com Services LLC90f40330-46a6-44cf-9b09-6f791c9b210b2025-05-12WarningsExact identifier
unii: 7AJO3BO7QN
non drowsy allergy reliefLORATADINEMeijer Distribution Inc4762c96e-d562-4f74-a275-8cba597987f92025-05-08WarningsExact identifier
unii: 7AJO3BO7QN
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI11e889d8-833c-4043-a1af-7ffaf3fda61d2025-05-07WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEMeijer Distribution Incb27f0bd0-4e61-4498-b5b7-54ae31f637f32025-05-07WarningsExact identifier
unii: 7AJO3BO7QN
dg health childrens allergyLORATADINEDolgencorp, LLC14acf572-e1f0-40f5-82cf-357cb2f3a0512025-05-07WarningsExact identifier
unii: 7AJO3BO7QN
good sense childrens allergy reliefLORATADINEL. Perrigo Company4ce244e2-9fbc-4371-8806-789fd3a61a092025-05-06WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEMeijer, Inc.f71d9155-e5fb-4735-86f6-59dd9abf6be02025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
equate childrens allergyLORATADINEWal-Mart Stores Inc5603d5e1-8d95-44b9-aceb-4bc37b162ab12025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
Good Sense childrens allergy reliefLORATADINEL. Perrigo Company637e309d-9846-45a1-ad11-f67ea85c87b82025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINESafeway8a1b3d40-8ec4-7e76-e053-2a95a90a84b12025-04-30WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEThe Kroger Company43e53450-9630-4161-8008-22267a7853432025-04-24WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEWAL-MART STORES, INC59453133-20bf-4f13-855a-b47b22302d8b2025-04-14WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEWinCo Foods, LLC706a59fa-3d15-4e6e-a38e-ad3f2ef466002025-04-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINEWAL-MART STORES, INCec24da65-23c1-419d-9603-08348d3b9cc72025-04-04WarningsExact identifier
unii: 7AJO3BO7QN
Leader Allergy ReliefLORATADINECardinal Health 110, LLC. dba Leader6f5134c6-ece6-4e35-a0c3-13e0dfa173fa2025-04-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
up and up allergy reliefLORATADINETarget Corporationc4ef0110-89c3-4ded-9a9a-75c0f794f8692025-03-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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