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 34 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Geovita	CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA	RUBIMED AG	0fcb5c06-d414-456c-a0ef-28e14018a781	2024-11-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d41602-9dcb-eaa8-e063-6394a90a7cfa	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d4ddaf-9c07-a7fc-e063-6394a90adc0b	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d5997b-1cae-41c2-e063-6394a90ac74a	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Loratadine 10mg	LORATADINE 10MG	MARKSANS PHARMA LIMITED	3360d02d-612d-4cc5-acc9-2cc93713c387	2024-11-25	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	cdecad62-bf1e-43fb-b4be-8fc54b63e4ae	2024-11-22	Warnings	Exact identifier unii: 7AJO3BO7QN
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	2787f88c-752e-cbaa-e063-6394a90a732c	2024-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Loratadine	LORATADINE	American Health Packaging	411f3692-99ff-49d7-8594-e6f404f5861f	2024-11-21	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	48bfc938-d97d-4b49-8637-3b00ac870902	2024-11-21	Warnings	Exact identifier unii: 7AJO3BO7QN
Hempvana Ultra Pain Relief - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	f93a1ed0-5046-0355-e053-6294a90a6a90	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix Corporation	37063a49-6b45-4167-875d-49c9dac3f79b	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Loratadine	LORATADINE	WALGREENS CO.	c9e12155-a699-4fa7-aac8-da7d5ddab4ae	2024-11-19	Warnings	Exact identifier rxcui: 665078 unii: 7AJO3BO7QN
good neighbor pharmacy childrens loratadine	LORATADINE	Amerisource Bergen	46cdccaf-a6f2-4a49-a2b0-7ba0df17bfa8	2024-11-19	Warnings	Exact identifier unii: 7AJO3BO7QN
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.	2be630bc-9fa6-42a6-b66d-99f91a58b1fa	2024-11-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier unii: XF417D3PSL
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	Pharmaceutical Associates, Inc.	63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5	2024-11-13	Adverse reactions	Exact identifier unii: XF417D3PSL
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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