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
Label	Manufacturer	Effective date	Type
Claritin - Bayer HealthCare LLC. \| Patheon Manufacturing Services LLC	Bayer HealthCare LLC. \| Patheon Manufacturing Services LLC	2025-12-05	HUMAN OTC DRUG LABEL
Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4331-1	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-1	Claritin	4 in 1 CARTON	TABLET, CHEWABLE	4	14
11523-4331-2	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-2	Claritin	6 in 1 CARTON	TABLET, CHEWABLE	6	14
11523-4331-6	Claritin	8 in 1 CARTON	TABLET, CHEWABLE	8	14
11523-4331-6	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-4331	CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]	13	Current NDC, Legacy NDC, 6 package rows	20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
D&C red No. 27	INACTIVE INGREDIENT	2LRS185U6K	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	CLARITIN (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 37 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bio Co-Enzyme Phase	CARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,	Deseret Biologicals, Inc.	afad858e-064f-454d-be78-da1501ffe853	2024-10-04	Warnings	Exact identifier unii: XF417D3PSL
EMF Protect and Balance	ALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA CUBENSIS, X-RAY, YTTERBIUM OXIDE	Deseret Biologicals, Inc.	9ea8dfe3-7d95-4b86-8e1f-dc9e414e854a	2024-10-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydration Complex	BOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA	Deseret Biologicals, Inc.	891265ff-2651-4d84-a77b-331e3eb7e3ec	2024-10-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Energy Catalyst	VISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,	Deseret Biologicals, Inc.	99529dd4-f8ab-4348-8b65-dc8c89e1ad54	2024-10-04	Warnings	Exact identifier unii: LMI26O6933
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1	ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE	Terumo Corporation	39f2e11c-5a31-469f-b725-d096c1674421	2024-10-03	Warnings	Exact identifier unii: XF417D3PSL
Loratadine Allergy Relief	LORATADINE	Proficient Rx LP	a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb	2024-10-01	Warnings	Exact identifier unii: 7AJO3BO7QN
Bone Support HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALE	Energique, Inc.	da6937b9-da23-4e78-96af-2ca40f973a02	2024-09-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Household Detox	PTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLON	Deseret Biologicals, Inc.	7e32c1f4-c88e-43d0-9f6c-de736d358d46	2024-09-27	Warnings	Exact identifier unii: LMI26O6933
Gut Brain Spectrum	ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM	Energique, Inc.	cb1566a4-92d4-4f1a-9211-f0c538a83c27	2024-09-27	Warnings	Exact identifier unii: LMI26O6933
Spectric	AGARICUS MUSCARIUS, ASPARTAME, BUFO RANA, CARCINOSIN, CEREBRUM SUIS, ETHYLICUM, HELLEBORUS NIGER, HYDROGEN, HYOSCYAMUS NIGER, KALI BROMATUM, L-DOPA, NEON, OLIBANUM (BOSWELLIA SERRATA), PLACENTA TOTALIS SUIS, SEROTONIN (HYDROCHLORIDE), STRAMONIUM, THUJA OCCIDENTALIS	Deseret Biologicals, Inc	4ee7f979-c30d-4062-a453-27b6b0b38247	2024-09-23	Warnings	Exact identifier unii: Z0H242BBR1
Lymphapar	ECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEA	Energique, Inc.	c746c111-7ebc-46c1-b11b-04271887df9c	2024-09-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
HP Axis	ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE	Deseret Biologicals, Inc.	402f5b05-c71e-4dba-bc2b-049aee42952a	2024-09-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood	ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE	Terumo Corporation	02015040-9b71-4dbe-8f8d-e0d0951e8f93	2024-09-19	Warnings	Exact identifier unii: XF417D3PSL
Spectric	ETHYLICUM, KALI BROMATUM, ASPARTAME, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGEN	Deseret Biologicals, Inc	d1981aca-de84-404d-8d38-3a013a531426	2024-09-11	Warnings	Exact identifier unii: Z0H242BBR1
Chronagesic	ARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUM	Deseret Biologicals, Inc.	66e351ed-d359-4367-a950-fc57b37489ab	2024-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
VACC HC	ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LAC FELINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM.	Deseret Biologicals, Inc.	a7536e3d-2cdb-49d7-9161-92ef64433883	2024-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Focus	GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGER	Deseret Biologicals, Inc.	e77857b8-be67-4041-8c8d-9772f17c6d06	2024-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mammaryplex	ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE)	BioActive Nutritional, Inc.	9c9ed6f6-8690-4fbd-8691-26dd577014a8	2024-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymph Liquescence	ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANA	Nutritional Specialties, Inc.	866ac8e1-431c-4c8b-b052-f6c4cff3769b	2024-09-05	Warnings	Exact identifier unii: ETJ7Z6XBU4
Curist Childrens Allergy Relief	LORATADINE 5 MG CHEWABLE TABLETS	Little Pharma, Inc.	1ab6a653-0b7c-69d7-e063-6394a90aacad	2024-09-03	Warnings	Exact identifier rxcui: 665078 unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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