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 7 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
LORATADINELORATADINEKROGER COMPANY0599cc64-419d-452f-ac50-ac03110067292025-12-29WarningsExact identifier
unii: 7AJO3BO7QN
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
ClaritinLORATADINESelect Consumer Group3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2025-12-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEGRANULES USA, INC.c3c9bc45-7ed5-abf4-e053-2995a90a40ff2025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENCS HealthCare of KY, LLC dba Vangard Labsf3d05276-21bd-419d-8dba-07ce278d33752025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINESafeway, Incf2a2a754-0170-e37c-e053-2a95a90a4dca2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine 10mgLORATADINE 10MGMeijer181b7dd1-ddc4-e799-e063-6294a90a9faa2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEWalgreensfd796139-ea9f-f4db-e053-6394a90acdf32025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEValu Merchandisers Company05927511-6b7a-4e29-96b4-3043493acf112025-12-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.660ac9df-f1b1-4c89-94dd-9fae0a013f3c2025-12-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer Healthcare LLC.b681ea25-d00b-4c8a-8054-cc6f983ce3372025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.37732ca2-b454-4215-91a2-c62e0f7a56af2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.f046a807-ab8c-0620-e053-2a95a90a9d3c2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
unii: 7AJO3BO7QN
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 12 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.a7125705-01ff-4418-8c53-9209c2bbb4842025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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