FDA.reportPublic FDA data

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 57 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
unii: 15FIX9V2JP
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
unii: 15FIX9V2JP
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEABOUT FACE AESTHETICS, INC.364728b4-e0ff-8466-e063-6394a90a00892025-12-10Exact identifier
unii: 15FIX9V2JP
tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d42661-e511-1dfc-e063-6294a90a9ed72025-12-10Exact identifier
unii: 15FIX9V2JP
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
unii: 15FIX9V2JP
Smoothing Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION32721b87-aef1-d759-e063-6394a90a40d32025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral StickTITANIUM DIOXIDE, ZINC OXIDEShelley Bennett Skincare326e9a14-5fb6-6a6e-e063-6294a90adece2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bafa0b-d253-c263-e063-6394a90ad1e42025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35ba578f-a842-7eec-e063-6394a90a11652025-12-10Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bc3994-1f72-2bbf-e063-6294a90ac2f12025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bccadf-6fc8-abd0-e063-6294a90aaa2e2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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