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 18 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEAMERIFOODS TRADING COMPANYf6ce5292-f698-dd2f-e053-6394a90ad74a2023-11-02WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
foster and thrive childrens allergy reliefLORATADINEStrategic Sourcing Services LLC5ac59de8-46ad-4731-8f98-167fb5f8b0892023-10-30WarningsExact identifier
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)9ea4fde8-e091-412d-9de1-dd66a2ab73e42023-10-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINE ORALBetter Living Brands LLCf7dc7a3d-6709-d7e7-e053-6394a90acde82023-09-26WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEBetter Living Brands, LLCfad93257-bfcf-5e04-e053-6394a90a10a62023-09-25WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINECamber Consumer Care Incd57da4bd-af37-414a-a50c-e80d2bb283142023-09-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
topcare allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATETopco Associates LLC32945cd9-60d4-4dc0-96e6-9ed28ffce3fb2023-08-29WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMeijer Distribution, Inc.eb6e2196-2f4f-4fe9-9c80-b4ce89da8db42023-08-23WarningsExact identifier
unii: 7AJO3BO7QN
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended ReleaseLORATADINE AND PSEUDOEPHEDRINE SULFATEKirkland-COSTCO WHOLESALE COMPANYb8e35d9f-5ad7-4cd5-b359-18f7dfe586c62023-08-23WarningsExact identifier
unii: 7AJO3BO7QN
Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.031fc3e5-b5eb-447c-e063-6294a90a13b52023-08-17WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI25329c7d-76e7-47b3-914e-ac367bbb750b2023-08-17WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESTRATEGIC SOURCING SERVICES LLC07f03186-438d-41b7-a871-f05a387333292023-08-11WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEAmerisource Bergend2524455-b6c4-442b-b139-666a555c52982023-07-10WarningsExact identifier
unii: 7AJO3BO7QN
kirkland signature allerclear d 12 hrLORATADINE, PSEUDOEPHEDRINE SULFATECostco Wholesale Company1534720b-f8f8-4db5-99e0-cfa49acf92992023-07-07WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEDr. Reddy's Laboratories Inc.d707733d-1ee9-92d3-f5b2-3567b9c217c22023-06-25WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEDr. Reddy's Laboratories Inc.bb6af6a4-aec0-ddf5-57b7-063504ca8e1e2023-06-25WarningsExact identifier
unii: 7AJO3BO7QN
topcare childrens allergy reliefLORATADINETopco Associates LLC4f7555ea-6286-4ff6-b125-d12660ae4bdf2023-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPLD Acquisitions LLC DBA Avma Pharma Solutions2edb53f8-7661-4e54-bb50-e03078bae3bf2023-05-04WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINERite Aid Corporationf8ddeb7e-94b1-4dce-815f-b6b8c71e88fd2023-04-13WarningsExact identifier
unii: 7AJO3BO7QN
Claritin, BSX Non-Drowsy, 24 HourLORATADINELil' Drug Store Products, Incf85b0527-107c-4a4a-aad7-61d2f52bad632023-03-17WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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