FDA.reportPublic FDA data

NDC 63548-0753-01 - 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
63548-0753
Requested NDC
63548-0753-01
Package NDCs from labels
63548-0753-3, 63548-0753-1, 63548-0753-0, 63548-0753-01
Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - PLD Acquisitions LLC DBA Avéma Pharma SolutionsPLD Acquisitions LLC DBA Avéma Pharma Solutions2023-05-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63548-0753-02023-02-09Drug Facts
63548-0753-12023-02-09Drug Facts
63548-0753-32023-02-09Drug Facts
63548-0753-02023-01-30Drug Facts
63548-0753-12023-01-30Drug Facts
63548-0753-32023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-0753-0Loratadine300 in 1 BOTTLE, PLASTICTABLET3006
63548-0753-1Loratadine100 in 1 BOTTLE, PLASTICTABLET1006
63548-0753-3Loratadine30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0753LORATADINE TABLET [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]6Current NDC, Legacy NDC, 3 package rows20230505_2edb53f8-7661-4e54-bb50-e03078bae3bf.zip

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 8 of 20 · 398 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
rxcui: 311372
unii: 7AJO3BO7QN
Gencare-Allergy Relief Loratadine Tablets, 10 mgLORATADINEPioneer Life Sciences, LLC647dc957-4aee-48f6-bb77-e82d3b380e802025-06-30WarningsExact identifier
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
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

Reported adverse events (FAERS/openFDA)#

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