FDA.reportPublic FDA data

NDC 11523-0101-01 - Claritin Allergy

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
11523-0101
Requested NDC
11523-0101-01
Package NDCs from labels
11523-0101-1, 11523-0101-2, 11523-0101-3, 11523-0101-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Claritin Liquid Cooling Honey UI 1613938Bayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0101-1ClaritinAllergy30 mL in 1 BOTTLESOLUTION302
11523-0101-1ClaritinAllergy1 in 1 CARTONSOLUTION12
11523-0101-2ClaritinAllergy1 in 1 CARTONSOLUTION12
11523-0101-2ClaritinAllergy80 mL in 1 BOTTLESOLUTION802
11523-0101-3ClaritinAllergy240 mL in 1 BOTTLESOLUTION2402
11523-0101-3ClaritinAllergy1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0101CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.]1Current NDC, 6 package rows20240612_19afd658-8c67-af44-e063-6394a90abada.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 27 of 62 · 1,223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: E4GA8884NN
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
Childrens Loratadine Sugar FreeLORATADINEH E Bd710b760-794e-490b-a413-c7b2ee5149b92025-08-14WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.d820e42d-ad2b-4e11-907b-a94d698ca2852025-08-13Warnings, Adverse reactionsExact identifier
unii: 3980JIH2SW
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
SYZ CEPHALANDRAACID PHOS, CEPHALANDRA IND, GYNMEMA SYL, MOMORDICA CHARANTIA, SYZ JAMBOLBM Private Limited3b3a3776-96c0-f876-e063-6394a90aaec82025-07-31WarningsExact identifier
unii: E4GA8884NN
Childrens Loratadine Sugar FreeLORATADINESTRATEGIC SOURCING SERVICES LLC809456dc-1d1c-42a7-b17f-e43dacde927f2025-07-30WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Allergy reliefLORATADINEGeri-Care Pharmaceutical Corpb66f171a-7b95-b27a-e053-2a95a90a60092025-07-28WarningsExact identifier
unii: 7AJO3BO7QN
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
LoratadineLORATADINEMylan Institutional Inc.1fc9ddd1-393d-4fe2-a9e0-d192df7331db2025-07-22WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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