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 4 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
unii: 7AJO3BO7QN
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.12c8066a-3429-481e-b63a-7ea2b439a1702026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.96a76906-58ad-40cd-be27-4ea254e298c52026-07-14WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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