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 4 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0e84571d-87b6-4742-ac62-9ed68a115c722026-03-17WarningsExact identifier
unii: 7AJO3BO7QN
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATECVS Pharmacy0ca2b074-7137-478c-b32c-67f834f6c4542026-03-15WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.c0e3057d-2dd2-de2b-e053-2995a90a1a1d2026-03-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company9952e0fb-b20e-4f9c-8be7-aa286e271fee2026-02-28WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.039f144b-891b-4ab0-e063-6394a90aa4c82026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.775885f9-0580-4eca-94d8-44fce1dcdccd2026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEATLANTIC BIOLOGICALS CORP.999a1080-5bbd-4027-b6e7-a90a6941ee272026-02-26WarningsExact identifier
unii: 7AJO3BO7QN
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINECVS Pharmacy0038bc38-c205-4d8d-ab78-1abbcd76829e2026-02-25WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINEKroger Company745d48f2-504d-4e3d-abf8-768d201cf8142026-02-24WarningsExact identifier
unii: 7AJO3BO7QN
Alavert AllergyLORATADINEFoundation Consumer Brandsf741d1cf-0ecb-4405-8596-07af394537db2026-02-23WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Berkley and Jensen Allergy ReliefLORATADINEBJWCe981a0ef-08e9-4ac3-92a1-411217e0a2512026-02-16WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticals60162446-4fa1-4ee3-ae20-19fadc2491ab2026-02-09WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESportpharm LLC2b432b67-f9f3-45e2-8306-2d4080152f992026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATESportpharm LLCbb54f613-b2ab-48fd-83c9-2038ec7097f62026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine OralLORATADINEAtlantic Biologicals4a1a6981-133c-d45b-e063-6294a90a4a092026-02-05WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEKroger Companydac0b200-6b02-4c8a-b1dd-a4d5341dfb2d2026-02-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEStrategic Sourcing Services, LLCa527f83a-4ae9-47b1-94e0-7ab3148b025f2026-01-29WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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