FDA.reportPublic FDA data

NDC 11523-4331-01 - 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
11523-4331
Requested NDC
11523-4331-01
Package NDCs from labels
11523-4331-1, 11523-4331-2, 11523-4331-6, 11523-4331-01
Manufacturer
Bayer HealthCare LLC. | Patheon Manufacturing Services 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
Claritin - Bayer HealthCare LLC. | Patheon Manufacturing Services LLCBayer HealthCare LLC. | Patheon Manufacturing Services LLC2025-12-05HUMAN OTC DRUG LABEL
Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741Bayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4331-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-1Claritin4 in 1 CARTONTABLET, CHEWABLE414
11523-4331-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-2Claritin6 in 1 CARTONTABLET, CHEWABLE614
11523-4331-6Claritin8 in 1 CARTONTABLET, CHEWABLE814
11523-4331-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4331CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 6 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
D&C red No. 27INACTIVE INGREDIENT2LRS185U6KCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2

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 53 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEWalgreen Companyab7e4406-997a-43be-af99-a07a2da870da2021-08-25WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Allergy ReliefLORATADINEH E B704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb2021-08-24WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN
Basic Care Childrens Allergy ReliefLORATADINEAmazon.com Services LLCe2c83874-aa95-477a-9cfd-cecfd776ba0e2021-08-12WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN
HLU PNEUMO DROPSARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARISSeroyal USA2f0acce5-aad5-1dd3-e054-00144ff88e882021-07-22WarningsExact identifier
unii: ETJ7Z6XBU4
Sleep AidADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
good sense allergy reliefLORATADINEL. Perrigo Companya8f97128-3af8-493d-8e66-a1e07f5941312021-07-14WarningsExact identifier
unii: 7AJO3BO7QN
SILICEA 6XSILICEASeroyal USA156cb778-c6a8-0681-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: ETJ7Z6XBU4
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefLORATADINEDISCOUNT DRUG MARTc29bf35f-1f19-c3c9-e053-2995a90ac1b62021-07-12WarningsExact identifier
unii: 7AJO3BO7QN
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.c67b3a39-ef78-5e81-e053-2a95a90a47862021-07-06WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
LoratadineLORATADINECardinal Health, 110 dba LEADERdb9d2182-6bf1-424a-a144-f2694c47989f2021-06-23WarningsExact identifier
unii: 7AJO3BO7QN
dg health allergy reliefLORATADINEDolgencorp, LLCc18c40ae-19c8-4699-842a-43a5c4c236d52021-06-22WarningsExact identifier
unii: 7AJO3BO7QN
Leader Allergy Relief D12LORATADINE, PSEUDOEPHEDRINE SULFATECardinal Health 110, LLC. dba Leader98bd6186-2bd2-4f46-99df-f509bb00e03a2021-06-17WarningsExact identifier
unii: 7AJO3BO7QN
leader childrens allergy reliefLORATADINECardinal Health 110, LLC. dba Leader20b438e1-f461-48fa-b007-4c02ecb91b682021-06-17WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEAMERISOURCE BERGEN96635cb0-8c78-4c3a-8294-2804ff26f90a2021-06-03WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEAmerisource Bergen3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c12021-06-03WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEHARRIS TEETERb8f67f52-906e-c7a8-e053-2995a90a5cbd2021-04-29WarningsExact identifier
unii: 7AJO3BO7QN
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens AllergyLORATADINEWal-Mart Stores Inc9fb3a3a8-8812-4238-b596-291b79085db92021-04-15WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEKROGER COMPANYf5fbfb52-197c-437c-8977-23bd7f2ac7bd2021-04-08WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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