FDA.reportPublic FDA data

NDC 11523-7162-01 - Claritin-D 12 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
11523-7162
Requested NDC
11523-7162-01
Package NDCs from labels
11523-7162-1, 11523-7162-2, 11523-7162-3, 11523-7162-01
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
Claritin-D ® 12 HourBayer HealthCare LLC.2025-12-05HUMAN OTC DRUG LABEL
Claritin-D ® 12 HourREMEDYREPACK INC.2022-11-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7162-1Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
11523-7162-1Claritin-D12 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE110
11523-7162-2Claritin-D12 Hour2 in 1 CARTONTABLET, EXTENDED RELEASE210
11523-7162-2Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
11523-7162-3Claritin-D12 Hour3 in 1 CARTONTABLET, EXTENDED RELEASE310
11523-7162-3Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7162CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 6 package rows20241208_a7125705-01ff-4418-8c53-9209c2bbb484.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7162-1EA - Each11523-716285cce7f3-cec5-4281-aaa0-08796678607d12012-07-24
11523-7162-2EA - Each11523-7162c215d904-7907-4d87-a34a-651e85e00f1212012-07-24
11523-7162-3EA - Each11523-7162a7d669e2-7d96-4d35-9050-88685311133312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
pseudoephedrine sulfateACTIVE INGREDIENTY9DL7QPE6BCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
pseudoephedrineACTIVE MOIETY7CUC9DDI9FCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
povidonesINACTIVE INGREDIENTFZ989GH94ECLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2

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 126 · 2,518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINE ORALKROGER COMPANYb963d83b-584f-c447-e053-2995a90ad9732026-07-06WarningsExact identifier
unii: 7AJO3BO7QN
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
dg health allergy reliefLORATADINEDolgencorp Incdfc4b065-1980-48ec-9c3e-aaa4a42214d32026-07-02WarningsExact identifier
unii: 7AJO3BO7QN
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
unii: 7AJO3BO7QN
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINESt. Mary's Medical Park Pharmacy2bc586e4-5297-44cf-e063-6294a90a531d2026-06-29WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEKroger Company52934db1-b6fc-43ca-9a8c-66ff47a947452026-06-29WarningsExact identifier
unii: 7AJO3BO7QN
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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