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 5 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Childrens Loratadine Sugar FreeLORATADINEPreferred Pharmaceuticals Inc.23936948-71bf-4c18-9160-22b7075e675d2026-01-15WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINEWalgreen Company42a73448-104a-4c7f-aea0-cef44d15f5f12026-01-13WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEAdvagen Pharma Limiteda5699a95-c0a7-43ea-9bab-bbfaba3c8aa52026-01-05Exact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEKROGER COMPANY0599cc64-419d-452f-ac50-ac03110067292025-12-29WarningsExact identifier
unii: 7AJO3BO7QN
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
ClaritinLORATADINESelect Consumer Group3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2025-12-28WarningsExact identifier
rxcui: 311372
rxcui: 206805
unii: 7AJO3BO7QN
LoratadineLORATADINEGRANULES USA, INC.c3c9bc45-7ed5-abf4-e053-2995a90a40ff2025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENCS HealthCare of KY, LLC dba Vangard Labsf3d05276-21bd-419d-8dba-07ce278d33752025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINESafeway, Incf2a2a754-0170-e37c-e053-2a95a90a4dca2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine 10mgLORATADINE 10MGMeijer181b7dd1-ddc4-e799-e063-6294a90a9faa2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEWalgreensfd796139-ea9f-f4db-e053-6394a90acdf32025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEValu Merchandisers Company05927511-6b7a-4e29-96b4-3043493acf112025-12-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.660ac9df-f1b1-4c89-94dd-9fae0a013f3c2025-12-05WarningsExact identifier
application number: NDA019658
ndc (package): 11523-7160-3
ndc (package): 11523-7160-7
ndc (package): 11523-4359-4
ndc (package): 11523-7160-6
ndc (package): 11523-7237-1
ndc (package): 11523-4359-8
ndc (package): 11523-7160-9
ndc (package): 11523-4359-9
ndc (package): 11523-7160-2
ndc (package): 11523-7237-5
ndc (package): 11523-7237-3
ndc (package): 11523-7237-9
ndc (package): 11523-7237-6
ndc (package): 11523-4359-1
ndc (package): 11523-4359-7
ndc (package): 11523-7160-5
ndc (package): 11523-7237-8
ndc (package): 11523-4359-3
ndc (package): 11523-4359-6
ndc (package): 11523-4359-5
ndc (package): 11523-7160-1
ndc (package): 11523-4359-2
ndc (package): 11523-7160-8
ndc (package): 11523-7237-7
ndc (package): 11523-1527-1
ndc (package): 11523-1527-2
ndc (product): 11523-4359
ndc (product): 11523-7237
ndc (product): 11523-7160
ndc (product): 11523-1527
ndc11 (package): 11523435901
rxcui: 311372
rxcui: 206805
spl id: 4536cd82-d67c-56be-e063-6294a90a7775
spl set id: 660ac9df-f1b1-4c89-94dd-9fae0a013f3c
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer Healthcare LLC.b681ea25-d00b-4c8a-8054-cc6f983ce3372025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.37732ca2-b454-4215-91a2-c62e0f7a56af2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.f046a807-ab8c-0620-e053-2a95a90a9d3c2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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