FDA.reportPublic FDA data

NDC 11523-4359-01 - Claritin

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
11523-4359
Requested NDC
11523-4359-01
Package NDCs from labels
11523-4359-1, 11523-4359-2, 11523-4359-3, 11523-4359-4, 11523-4359-5, 11523-4359-6, 11523-4359-8, 11523-4359-9, 11523-4359-7, 11523-4359-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamineBayer HealthCare LLC.2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4359-1Claritin40 in 1 BOTTLETABLET4012
11523-4359-1Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin100 in 1 BOTTLETABLET10012
11523-4359-3Claritin90 in 1 BOTTLETABLET9012
11523-4359-3Claritin1 in 1 CARTONTABLET112
11523-4359-4Claritin55 in 1 BOTTLETABLET5512
11523-4359-4Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin85 in 1 BOTTLETABLET8512
11523-4359-6Claritin110 in 1 BOTTLETABLET11012
11523-4359-6Claritin1 in 1 CARTONTABLET112
11523-4359-7Claritin1 in 1 BLISTER PACKTABLET112
11523-4359-7Claritin115 in 1 BOTTLETABLET11512
11523-4359-8Claritin60 in 1 BOTTLETABLET6012
11523-4359-8Claritin2 in 1 BLISTER PACKTABLET212
11523-4359-9Claritin1 in 1 CARTONTABLET112
11523-4359-9Claritin35 in 1 BOTTLETABLET3512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4359CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 18 package rows20221015_660ac9df-f1b1-4c89-94dd-9fae0a013f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4359-1EA - Each11523-4359ec560d72-229c-43c8-b999-35c4b11a066e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4

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 10 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine ODTLORATADINECVS Pharmacy, Inc.37443f0d-bda0-4ddc-a2dd-f3daf495cb402025-03-17WarningsExact identifier
unii: 7AJO3BO7QN
dg health allergy reliefLORATADINEDolgencorp Inc086a0a53-7092-4dc8-9c5e-0bd78337fedf2025-03-11WarningsExact identifier
unii: 7AJO3BO7QN
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATEPadagis Israel Pharmaceuticals Ltd01e61c73-3b81-4683-b1a9-8784c0d565b12025-03-03WarningsExact identifier
unii: 7AJO3BO7QN
ValuMeds Allergy ReliefLORATADINECabinet Health P.B.C.7a67f879-9df9-4536-8fd5-4b9aed05fb472025-02-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEAdvanced Rx LLCe96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d2025-02-25WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEA-S Medication Solutions0be70365-57ee-4f2e-a30f-bdd5c292992d2025-02-20WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsbaaf9c23-0b54-46a2-8aec-13264479a6d72025-02-20WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINEMeijer, Inc.14f3d1a2-eda7-432a-8fe0-5437b95bdde62025-02-14WarningsExact identifier
unii: 7AJO3BO7QN
topcare allergy reliefLORATADINETopco Associates LLC5cc2e469-9080-4beb-804d-187fc335ccdc2025-02-10WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.fc63689e-e449-ca8f-e053-6394a90a54a22025-02-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy reliefLORATADINEBryant Ranch Prepacke87aa69c-9ec6-482d-8e28-32542f6b91662025-02-04WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINETARGET CORPORATION7cb1364b-0852-3444-e053-2991aa0a36292025-02-01WarningsExact identifier
unii: 7AJO3BO7QN
Allergy reliefLORATADINEA-S Medication Solutions210fa77a-e33e-48c4-8228-b1cf3ccb7fa42025-01-30WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEGobrands, Inc1d182bd6-ad72-4352-b983-407a48c317f02025-01-25WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine 10 mgLORATADINE TABLETS USP, 10 MGTIME CAP LABORATORIES, INC.2c80ea14-8490-4d26-e063-6294a90aecf02025-01-24WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEWal-Mart Stores, Inc.7679ee14-08aa-459c-9107-1a71443799622025-01-23WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBryant Ranch Prepack7f97595b-9df7-4834-82f0-5e4ce329c1182025-01-21WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINE ORALAurohealth LLC0b86a9fe-db7e-470a-a8fa-d7d4373116ba2025-01-20WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.54b37bcc-a8b0-0c17-e054-00144ff8d46c2025-01-09WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LORATADINELORATADINEAMZ789 LLCdb71197e-d633-644d-e053-2a95a90a261d2025-01-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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