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 2 of 62 · 1,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
CVS Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCVS PHARMACYf6f7568b-3887-434d-9403-a3ecdc591bbc2026-08-17WarningsExact identifier
unii: E4GA8884NN
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
unii: E4GA8884NN
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: E4GA8884NN
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: E4GA8884NN
AdrenapathCARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE)Energetix Corporationc300b8f5-4334-4597-a303-8200cbc117d12026-08-11WarningsExact identifier
unii: E4GA8884NN
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: E4GA8884NN
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: E4GA8884NN
Medi-ChordHOMEOPATHIC LIQUIDEnergetix Corporation57bc618b-15bd-4d04-8037-fb192e743e302026-08-11WarningsExact identifier
unii: E4GA8884NN
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: E4GA8884NN
ThyropathAVENA SATIVA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CHELIDONIUM MAJUS, FERRUM IODATUM, FUCUS VESICULOSUS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, IODIUM, KALI IODATUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), PYRIDOXINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), ZINCUM METALLICUMEnergetix Corporationf8ec1c51-520c-4bbe-8701-e875ea88a6282026-08-11WarningsExact identifier
unii: E4GA8884NN
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: E4GA8884NN
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: E4GA8884NN
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
LoratadineLORATADINEMajor Pharmaceuticals98e41ae1-677a-4583-9a0a-edba29ebbc302026-08-07WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Loratadine ODTLORATADINERugby Laboratoriesf59f3400-da77-4eb7-be02-842071d87fae2026-08-07WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INC2e75a831-eccc-4179-a4e3-9844be24bcda2026-08-05WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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