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 35 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	70d265de-ff94-e0e4-e053-2a91aa0a962a	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	9f7d0c96-a561-a8a0-e053-2995a90a250b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
WinCo Foods Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET	WinCo Foods, LLC	0c8a755a-089f-477f-97e9-0dd6fdfbe99d	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Focus	ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM	Deseret Biologicals, Inc.	e014e6b6-a07a-4170-b9af-f477da71597d	2024-11-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Chronagesic	ALPHA-LIPOICUM ACIDUM, APIOLUM, ARNICA MONTANA, CARTILAGO SUIS, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, PIPER NIGRUM, RHUS TOX, SANGUINARIA CANADENSIS, SULPHUR, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS	Deseret Biologicals, Inc.	1e340282-dbd9-44d7-9924-807f4099cf0c	2024-11-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	76e35b3f-3382-4e14-a25f-5544c75ff7c8	2024-11-05	Warnings	Exact identifier unii: 7AJO3BO7QN
Sinus Congestion Headache	ANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUM	Liddell Laboratories, Inc.	debc7747-8664-4598-a862-e295188c4fca	2024-11-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Vaccines	ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS	Liddell Laboratories, Inc.	6e6e67d4-089e-4775-b4a4-5511953f6e3f	2024-11-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
XS H2O Liquescence	VALERIANA OFFICINALIS, CITRICUM ACIDUM, POTASSIUM BITARTRATE, ALLIUM SATIVUM, ARTERIA SUIS, CEREBRUM SUIS, KIDNEY (SUIS) RAUWOLFIA SERPENTINA, ADRENOCORTICOTROPHIN	Nutritional Specialties, Inc.	16a266cd-79cc-4f1d-839c-45183107e82c	2024-10-31	Warnings	Exact identifier unii: XF417D3PSL
Vaccistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM	Energique, Inc.	8c8d63b6-763a-44f8-87ef-e83a89ec3776	2024-10-31	Warnings	Exact identifier unii: LMI26O6933 unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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