FDA.reportPublic FDA data

NDC 11523-4328-07 - 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
11523-4328
Requested NDC
11523-4328-07
Package NDCs from labels
11523-4328-1, 11523-4328-2, 11523-4328-3, 11523-4328-5, 11523-4328-4, 11523-4328-7, 11523-4328-9, 11523-4328-6, 11523-4328-07
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
LabelManufacturerEffective dateType
Claritin - Bayer HealthCare LLC. | Patheon Manufacturing Services LLCBayer HealthCare LLC. | Patheon Manufacturing Services LLC2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4328-1Claritin1 in 1 CARTONTABLET, CHEWABLE114
11523-4328-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-2Claritin2 in 1 CARTONTABLET, CHEWABLE214
11523-4328-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-3Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-3Claritin3 in 1 CARTONTABLET, CHEWABLE314
11523-4328-4Claritin1 in 1 POUCHTABLET, CHEWABLE114
11523-4328-4Claritin2 in 1 BLISTER PACKTABLET, CHEWABLE214
11523-4328-5Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-5Claritin5 in 1 CARTONTABLET, CHEWABLE514
11523-4328-6Claritin2 in 1 POUCHTABLET, CHEWABLE214
11523-4328-6Claritin50 in 1 BOXTABLET, CHEWABLE5014
11523-4328-7Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-7Claritin2.5 in 1 PACKAGE, COMBINATIONTABLET, CHEWABLE2.514
11523-4328-9Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4328-9Claritin4 in 1 CARTONTABLET, CHEWABLE414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4328CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 16 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4328-1EA - Each11523-43285114fcbe-6e66-40a3-a5d0-0bf035e03df112013-08-02
11523-4328-2EA - Each11523-432886b533c8-7143-4bb8-b69c-c54ff9fa410d12013-08-02
11523-4328-3EA - Each11523-4328529e2357-052f-420a-93c8-e901a203bdda12013-08-02
11523-4328-5EA - Each11523-43287fe6ee37-c9c5-4b72-aabf-364bc3e0878812015-10-02
11523-4328-7EA - Each11523-4328a605aa3e-7379-4ca1-83ea-42f0100ecbcb12022-06-06
11523-4328-9EA - Each11523-43289c176afb-b4fb-4f1c-9967-4be854b03b8612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
D&C red No. 27INACTIVE INGREDIENT2LRS185U6KCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLARITIN (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 1 of 59 · 1,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATERite Aid Corporationf08ebf00-a1d7-4a6f-a84f-195d000de53d2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
loratadineLORATADINERite Aid Corporation7b804f66-9323-4119-a856-1e6f082807812026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEYYBA CORP5a71de5c-a844-9dd4-e063-6294a90af0152026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172026-08-30WarningsExact identifier
unii: 7AJO3BO7QN
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-08-28WarningsExact identifier
unii: 7AJO3BO7QN
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
childrens allergy reliefLORATADINEAmazon.com Services LLC74bc9e66-2bd0-457f-b2c4-5b4c6a1e689c2026-08-20WarningsExact identifier
unii: 7AJO3BO7QN
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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