FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Claritin - Bayer HealthCare LLC. | Patheon Manufacturing Services LLCBayer HealthCare LLC. | Patheon Manufacturing Services LLC2025-12-05HUMAN OTC DRUG LABEL
Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741Bayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4331-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-1Claritin4 in 1 CARTONTABLET, CHEWABLE414
11523-4331-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-2Claritin6 in 1 CARTONTABLET, CHEWABLE614
11523-4331-6Claritin8 in 1 CARTONTABLET, CHEWABLE814
11523-4331-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4331CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 6 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

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 50 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine ODTLORATADINEAhold U.S.A., Inc,092aec8d-57d5-4487-8e1a-b4b586bee7cf2022-11-04WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEWal-Mart Stores, Inc.f399f7ab-ab51-46ff-bce9-3014eb0219302022-11-04WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEAurohealth LLC1ba8e521-0b0f-419c-b7c3-fa9586f83f362022-11-03WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEAurohealth LLC9f44382f-c289-402d-bb98-ec5fa80fc25d2022-11-03WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEAurohealth LLC8c119b12-f512-4207-b354-7244d1f9963a2022-11-03WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAurohealth LLC839e2e03-9ebb-4a44-b753-fb174bd361152022-11-03WarningsExact identifier
unii: 7AJO3BO7QN
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
basic care allergy reliefLORATADINEAmazon.com Services LLCa4a7f024-972b-4a16-9cb8-28954c2a74c62022-10-18WarningsExact identifier
unii: 7AJO3BO7QN
dg health allergy reliefLORATADINEDolgencorp, LLC04258018-3d57-46d7-9595-04786da3f51a2022-10-13WarningsExact identifier
unii: 7AJO3BO7QN
welby childrens allergy reliefLORATADINEAldi Inc402c635d-4116-4767-baa9-e956fed028842022-09-26WarningsExact identifier
unii: 7AJO3BO7QN
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
LoratadineLORATADINEWinco Foods, LLC.2a6cf697-0084-4522-bc89-b3e0f96a598d2022-08-17WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEWALGREENS CO.71adc5b3-3a91-4a1f-acb3-78922a7d9d5a2022-08-09WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN
Loratadine ODTLORATADINEAurohealth LLCa6e04fe7-23d3-47d7-9f18-5c4298fbc28b2022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINERITE AID322d9a03-a908-4858-b25e-6eba2411fa032022-06-02WarningsExact identifier
rxcui: 665078
unii: 7AJO3BO7QN
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z0H242BBR1

Reported adverse events (FAERS/openFDA)#

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