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 20 of 62 · 1,223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 12 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.a7125705-01ff-4418-8c53-9209c2bbb4842025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: E4GA8884NN
Anti Nausea Liquid Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)743b215a-81cc-408c-9375-4f427161a05b2025-12-04WarningsExact identifier
unii: E4GA8884NN
QUALITY CHOICE Anti-NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)68207fa3-3f69-4405-9191-be702e1bf5202025-12-04WarningsExact identifier
unii: E4GA8884NN
ClaritinLORATADINEBayer HealthCare LLCac32d6f9-f553-4d5c-ad36-575af5ea56de2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.f3b9c643-a605-7702-e053-2995a90a61302025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.3ea6a90b-8cb1-46b0-9ff7-be7090245e532025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Claritin AllergyLORATADINEBayer HealthCare LLC.19afd658-8c67-af44-e063-6394a90abada2025-12-04WarningsExact identifier
application number: NDA020641
ndc (package): 11523-0101-1
ndc (package): 11523-0101-2
ndc (package): 11523-0101-3
ndc (product): 11523-0101
ndc11 (package): 11523010101
rxcui: 755476
rxcui: 692783
spl id: 4526da60-c33b-fb4a-e063-6294a90a8692
spl set id: 19afd658-8c67-af44-e063-6394a90abada
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.dc65f7ec-bb83-7b29-e053-2995a90a99de2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Walgreen Anti Nausea Cherry FlavorPHOSPHORATED CARBOHYDRATEWALGREENS CO.69e72d30-feca-454d-addc-8ed7325568d32025-12-01WarningsExact identifier
unii: E4GA8884NN
CAREALL Allergy ReliefLORATADINENew World Imports4d15d926-9564-4bef-b8a9-768af7a0ab6a2025-12-01WarningsExact identifier
unii: 7AJO3BO7QN
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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