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 19 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATESafewaye1993d05-248e-48da-838c-068f8263c2eb2021-03-08WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INC28a0c2b7-f793-43ac-90bc-c155ad141eaf2021-01-21WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINESAFEWAY7440046f-bf2f-438f-a320-3425d593d1a62021-01-21WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINERITE AIDdce7f475-baa9-4f19-ac49-fb1303786ace2021-01-12WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINEUP & UP9660f7e6-3a29-4a6d-ba57-92088f624aa42020-11-19WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINE 10MGFirst Aid Direct3a580dc7-ff09-462c-9b18-2051053490352020-11-12WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEPublix Super Markets Inc8209d7d5-4ecc-4170-ba50-5917bd8c46d42020-10-19WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEMarc Glassman, Inc.717ccb47-e13c-4464-b6e6-bea8f24d46632020-09-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLCc22c9880-ed0e-48a7-a30e-41f0aed5a2122020-09-03WarningsExact identifier
unii: 7AJO3BO7QN
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLC2a834b33-5759-4e54-9adc-379310656dee2020-08-19WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAurohealth LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
careone childrens allergy reliefLORATADINEAmerican Sales Company06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882020-08-10WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESTRATEGIC SOURCING SERVICES114b5e7c-973a-4a34-8538-a214de090b392020-07-30WarningsExact identifier
unii: 7AJO3BO7QN
Good Neighbor Pharmacy Childrens LoratadineLORATADINEAmerisourceBergen3ffc656a-90f9-4921-9c4f-840023b984332020-06-24WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEAllegiant Healthf0db3a13-43e6-4243-9a3a-7808ddd005e12020-06-16WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
dg health childrens allergy reliefLORATADINEDolgencorp, LLC302fc570-bec9-43cb-8965-139576102cdd2020-06-10WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAphena Pharma Solutions - Tennessee, LLC8ffe2faf-3253-4121-a069-6f46e319c6f02020-05-13WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
good sense allergy reliefLORATADINEL. Perrigo Company74bed4ad-5afe-4293-bef3-e0b9d5f64a292019-12-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEProficient Rx LPca1a6552-d082-4312-ba17-0055e8554eb92019-12-01WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEPUBLIX SUPER MARKETS INC8465d458-b3a7-4ada-a7de-1555942d176b2019-08-07WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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