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 42 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lung Large Intestine Meridian Opener	ALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHUR	Deseret Biologicals, Inc	a5c17770-e1c0-48e7-8947-c0434c22cdab	2024-02-21	Warnings	Exact identifier unii: LMI26O6933
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	a030afc6-9248-4e6a-a814-bd700c053e5c	2024-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cough	IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	4a8deb4a-9f26-46a9-8d99-99df36407f22	2024-02-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Perfect Sleep	ADENOSINUM 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)	Deseret Biologicals, Inc.	6d934960-63c6-4536-bde3-38c26f8083dc	2024-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Exact identifier unii: 7AJO3BO7QN
Silicea	SILICON DIOXIDE	SEVENE USA	0805d866-ce1a-4f54-8a44-83d4902e8c0d	2024-01-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Sleep Tight	ADENOSINUM 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)	Dr. Donna Restivo DC	b5955fbc-71f8-4fe0-9df0-42f337ab9c7d	2024-01-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	Wal-Mart Stores, Inc	f62c48ab-8dd3-4ed1-a123-d478efe8e839	2024-01-11	Warnings	Exact identifier rxcui: 665078 unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINE	LORATADINE	WAL-MART STORES, INC	01d6de60-58b0-453f-a0be-95146ce29ea3	2024-01-11	Warnings	Exact identifier rxcui: 665078 unii: 7AJO3BO7QN
Childrens Loratadine	LORATADINE	Ohm Laboratories Inc.	c088c998-d823-4bd0-9382-b567221f85a7	2024-01-11	Warnings	Exact identifier rxcui: 665078 unii: 7AJO3BO7QN
A01 CELLULAR RECHARGE	ACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA	Apex Energetics Inc.	b932ebd3-afea-6a95-e053-2995a90a2735	2024-01-08	Warnings	Exact identifier unii: XF417D3PSL
A12 DTX-KIDNEY	APIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREA	Apex Energetics Inc.	bf52e26f-aa27-87ca-e053-2995a90a23e7	2024-01-08	Warnings	Exact identifier unii: XF417D3PSL
A05 HEAVY ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUM	Apex Energetics Inc.	b9bdc39e-8ebf-615c-e053-2a95a90afe1b	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
C08 CALCIUM METABOLISM	ABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN D	Apex Energetics Inc.	bd09a34f-1615-09f0-e053-2995a90ac2ef	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F10 WRMLV	AGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINE	Apex Energetics Inc.	bf020c17-578d-74c4-e053-2995a90a9e7d	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F09 LTGO	ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS	Apex Energetics Inc.	bd1e652f-b3a4-c5bd-e053-2995a90ae03f	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
N01 PROTOMER	ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM	Apex Energetics Inc.	bfc8e049-2f62-31c4-e053-2a95a90a6e16	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F25 LF-CHNGS	AGRIMONY FLOWER	Apex Energetics Inc.	bf3c7a21-0e4e-6395-e053-2a95a90a7156	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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