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 26 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINE ORALBluePoint Laboratoriesab820f80-b5fc-7896-e053-2995a90a4b1c2025-05-15WarningsExact identifier
unii: 7AJO3BO7QN
Children Claritin AllergyLORATADINEBayer HealthCare LLC.170061e9-e529-4ff0-e054-00144ff8d46c2025-05-15WarningsExact identifier
unii: 7AJO3BO7QN
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
basic care childrens allergy reliefLORATADINEAmazon.com Services LLC90f40330-46a6-44cf-9b09-6f791c9b210b2025-05-12WarningsExact identifier
unii: 7AJO3BO7QN
non drowsy allergy reliefLORATADINEMeijer Distribution Inc4762c96e-d562-4f74-a275-8cba597987f92025-05-08WarningsExact identifier
unii: 7AJO3BO7QN
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI11e889d8-833c-4043-a1af-7ffaf3fda61d2025-05-07WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEMeijer Distribution Incb27f0bd0-4e61-4498-b5b7-54ae31f637f32025-05-07WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN
dg health childrens allergyLORATADINEDolgencorp, LLC14acf572-e1f0-40f5-82cf-357cb2f3a0512025-05-07WarningsExact identifier
unii: 7AJO3BO7QN
good sense childrens allergy reliefLORATADINEL. Perrigo Company4ce244e2-9fbc-4371-8806-789fd3a61a092025-05-06WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEMeijer, Inc.f71d9155-e5fb-4735-86f6-59dd9abf6be02025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
equate childrens allergyLORATADINEWal-Mart Stores Inc5603d5e1-8d95-44b9-aceb-4bc37b162ab12025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
Good Sense childrens allergy reliefLORATADINEL. Perrigo Company637e309d-9846-45a1-ad11-f67ea85c87b82025-05-05WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINESafeway8a1b3d40-8ec4-7e76-e053-2a95a90a84b12025-04-30WarningsExact identifier
unii: 7AJO3BO7QN
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEThe Kroger Company43e53450-9630-4161-8008-22267a7853432025-04-24WarningsExact identifier
unii: 7AJO3BO7QN
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEWAL-MART STORES, INC59453133-20bf-4f13-855a-b47b22302d8b2025-04-14WarningsExact identifier
unii: 7AJO3BO7QN
Bestmade Natural Products BM133 PelletsSILICEA, CARBO VEG, AURUM MUR, THUJA OCC, ACID NIT, FERRUM IODBestmade Natural Products3242a579-23f3-0063-e063-6394a90a93342025-04-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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