FDA.reportPublic FDA data

NDC 11523-4359-01 - 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
11523-4359
Requested NDC
11523-4359-01
Package NDCs from labels
11523-4359-1, 11523-4359-2, 11523-4359-3, 11523-4359-4, 11523-4359-5, 11523-4359-6, 11523-4359-8, 11523-4359-9, 11523-4359-7, 11523-4359-01
Manufacturer
Bayer HealthCare 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
Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamineBayer HealthCare LLC.2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4359-1Claritin40 in 1 BOTTLETABLET4012
11523-4359-1Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin100 in 1 BOTTLETABLET10012
11523-4359-3Claritin90 in 1 BOTTLETABLET9012
11523-4359-3Claritin1 in 1 CARTONTABLET112
11523-4359-4Claritin55 in 1 BOTTLETABLET5512
11523-4359-4Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin85 in 1 BOTTLETABLET8512
11523-4359-6Claritin110 in 1 BOTTLETABLET11012
11523-4359-6Claritin1 in 1 CARTONTABLET112
11523-4359-7Claritin1 in 1 BLISTER PACKTABLET112
11523-4359-7Claritin115 in 1 BOTTLETABLET11512
11523-4359-8Claritin60 in 1 BOTTLETABLET6012
11523-4359-8Claritin2 in 1 BLISTER PACKTABLET212
11523-4359-9Claritin1 in 1 CARTONTABLET112
11523-4359-9Claritin35 in 1 BOTTLETABLET3512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4359CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 18 package rows20221015_660ac9df-f1b1-4c89-94dd-9fae0a013f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4359-1EA - Each11523-4359ec560d72-229c-43c8-b999-35c4b11a066e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4

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 3 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CONTAC AllergyLORATADINEVespyr Brands LLC4587a61d-139e-2a5b-e063-6394a90a13112026-05-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
good sense allergy reliefLORATADINEL. Perrigo Company80e8a6e8-0c5f-4065-9545-112e146d25ee2026-04-27WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
MEDIQUE LoradamedLORATADINESportpharm LLCd6bf0e68-f87c-49ee-a15d-df7f5bfa62212026-04-24WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
LoratadineLORATADINEPreferred Pharmaceuticals Inc.7ca5050a-328a-4aff-8954-58f092e3ed6b2026-04-21WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
good sense childrens allergy reliefLORATADINEL. Perrigo Company643dfe16-9cd1-47bb-8bce-303e6885c6442026-04-20WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)80958503-400c-422a-a641-e1a3d5a9a6a82026-04-17WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINECamber Consumer Care Inc4dec6d48-78e0-48a4-9274-25f6cbf26a2c2026-04-10WarningsExact identifier
unii: 7AJO3BO7QN
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company7e6ea563-cc79-4683-b600-0691e0fb78ab2026-04-09WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d02026-04-08WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESafecor Health, LLC14d1ecf5-d694-4ce0-87e4-df27f3f4d9092026-03-31WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LORATADINELORATADINECVS HEALTH CORP899800a7-89bc-4a39-88b0-f19d78934daf2026-03-26WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINECVS Pharmacy, Inc.3937f769-e8e2-4b32-8338-21b0a74a86972026-03-20WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEPD-Rx Pharmaceuticals, Inc.7127b39d-3686-4249-b720-43c02b4c46542026-03-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Childrens Loratadine OralLORATADINEA-S Medication Solutions0a42baae-554b-4b93-8780-fe45c42fabc02026-03-18WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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