FDA.reportPublic FDA data

NDC 11523-4331-01 - 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
11523-4331
Requested NDC
11523-4331-01
Package NDCs from labels
11523-4331-1, 11523-4331-2, 11523-4331-6, 11523-4331-01
Manufacturer
Bayer HealthCare LLC. | Patheon Manufacturing Services 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 - Bayer HealthCare LLC. | Patheon Manufacturing Services LLCBayer HealthCare LLC. | Patheon Manufacturing Services LLC2025-12-05HUMAN OTC DRUG LABEL
Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741Bayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4331-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-1Claritin4 in 1 CARTONTABLET, CHEWABLE414
11523-4331-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-2Claritin6 in 1 CARTONTABLET, CHEWABLE614
11523-4331-6Claritin8 in 1 CARTONTABLET, CHEWABLE814
11523-4331-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4331CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 6 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
D&C red No. 27INACTIVE INGREDIENT2LRS185U6KCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLARITIN (LORATADINE) TABLET, CHEWABLE [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 18 of 59 · 1,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
application number: NDA021891
unii: 7AJO3BO7QN
Claritin-D 12 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.a7125705-01ff-4418-8c53-9209c2bbb4842025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLCac32d6f9-f553-4d5c-ad36-575af5ea56de2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: XF417D3PSL
ClaritinLORATADINEBayer HealthCare LLC.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: XF417D3PSL
ClaritinLORATADINEBayer HealthCare LLC.f3b9c643-a605-7702-e053-2995a90a61302025-12-04WarningsExact identifier
rxcui: 668469
rxcui: 665078
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.3ea6a90b-8cb1-46b0-9ff7-be7090245e532025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Claritin AllergyLORATADINEBayer HealthCare LLC.19afd658-8c67-af44-e063-6394a90abada2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
Claritin Chewable Grape and BubblegumLORATADINEBayer HealthCare LLC.0371368b-dca6-af2f-e063-6394a90a0ac02025-12-04WarningsExact identifier
application number: NDA021891
ndc (package): 11523-0123-1
ndc (product): 11523-0123
rxcui: 668469
rxcui: 665078
spl id: 4526df19-7a6e-0f19-e063-6394a90a3954
spl set id: 0371368b-dca6-af2f-e063-6394a90a0ac0
ClaritinLORATADINEBayer HealthCare LLC.dc65f7ec-bb83-7b29-e053-2995a90a99de2025-12-04WarningsExact identifier
unii: 7AJO3BO7QN
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
CAREALL Allergy ReliefLORATADINENew World Imports4d15d926-9564-4bef-b8a9-768af7a0ab6a2025-12-01WarningsExact identifier
unii: 7AJO3BO7QN
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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