NDC 11523-0102-01 - Claritin-D 24 Hour

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
11523-0102
Requested NDC
11523-0102-01
Package NDCs from labels
11523-0102-1, 11523-0102-2, 11523-0102-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Claritin-D ® 24 HourBayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0102-1Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE19
11523-0102-1Claritin-D24 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
11523-0102-2Claritin-D24 Hour15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE159
11523-0102-2Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0102CLARITIN-D 24 HOUR (LORATADINE PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 4 package rows20231201_3ea6a90b-8cb1-46b0-9ff7-be7090245e53.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0102-2EA - Each11523-0102b041a47b-0d88-472d-95c4-bc0de0fc496d12023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
pseudoephedrine sulfateACTIVE INGREDIENTY9DL7QPE6BCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
pseudoephedrineACTIVE MOIETY7CUC9DDI9FCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94ECLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]1

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 64 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
unii: 7AJO3BO7QN
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.660ac9df-f1b1-4c89-94dd-9fae0a013f3c2025-12-05WarningsExact identifier
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
rxcui: 1242391
rxcui: 1117562
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
unii: 7AJO3BO7QN
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 12 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.a7125705-01ff-4418-8c53-9209c2bbb4842025-12-05WarningsExact identifier
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
ClaritinLORATADINEBayer HealthCare LLCac32d6f9-f553-4d5c-ad36-575af5ea56de2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.f3b9c643-a605-7702-e053-2995a90a61302025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.3ea6a90b-8cb1-46b0-9ff7-be7090245e532025-12-04WarningsExact identifier
application number: ANDA075706
ndc (package): 11523-0102-1
ndc (package): 11523-0102-2
ndc (product): 11523-0102
ndc11 (package): 11523010201
rxcui: 1242391
rxcui: 1117562
spl id: 4526d9ef-02fb-338e-e063-6394a90af108
spl set id: 3ea6a90b-8cb1-46b0-9ff7-be7090245e53
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
Claritin AllergyLORATADINEBayer HealthCare LLC.19afd658-8c67-af44-e063-6394a90abada2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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