FDA.reportPublic FDA data

NDC 11523-4360-01 - Children 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
11523-4360
Requested NDC
11523-4360-01
Package NDCs from labels
11523-4360-5, 11523-4360-2, 11523-4360-6, 11523-4360-4, 11523-4360-7, 11523-4360-3, 11523-4360-1, 11523-4360-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's Claritin Allergy (Grape Flavor)Bayer HealthCare LLC.2025-05-15HUMAN OTC DRUG LABEL
Children's Claritin Allergy (Grape Flavor)Bayer HealthCare LLC.2017-05-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4360-1Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-1Children ClaritinAllergy60 mL in 1 BOTTLESOLUTION6018
11523-4360-2Children ClaritinAllergy120 mL in 1 BOTTLESOLUTION12018
11523-4360-2Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy150 mL in 1 BOTTLESOLUTION15018
11523-4360-4Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-4Children ClaritinAllergy30 mL in 1 BOTTLESOLUTION3018
11523-4360-5Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-5Children ClaritinAllergy240 mL in 1 BOTTLESOLUTION24018
11523-4360-6Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-6Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018
11523-4360-7Children ClaritinAllergy2 in 1 CARTONSOLUTION218
11523-4360-7Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4360CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.]18Current NDC, Legacy NDC, 14 package rows20250519_170061e9-e529-4ff0-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4360-5ML - Milliliter11523-4360a5947025-273d-428e-9bc1-8472d5c4fae912019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1

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 62 · 1,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGY RELIEFLORATADINEMeijer, Inc.190ecdc3-454a-4623-9e4a-09f4ab8650842026-07-09WarningsExact identifier
unii: 7AJO3BO7QN
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
allergy and nasal congestionLORATADINE, PSEUDOEPHEDRINE SULFATEKroger Company934dda74-7995-46f1-b6f2-f4b928a2eeb22026-07-08WarningsExact identifier
unii: 7AJO3BO7QN
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
LoratadineLORATADINE ORALKROGER COMPANYb963d83b-584f-c447-e053-2995a90ad9732026-07-06WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
dg health allergy reliefLORATADINEDolgencorp Incdfc4b065-1980-48ec-9c3e-aaa4a42214d32026-07-02WarningsExact identifier
unii: 7AJO3BO7QN
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESt. Mary's Medical Park Pharmacy2bc586e4-5297-44cf-e063-6294a90a531d2026-06-29WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEKroger Company52934db1-b6fc-43ca-9a8c-66ff47a947452026-06-29WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
unii: E4GA8884NN
unii: 506T60A25R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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