FDA.reportPublic FDA data

NDC 11523-4360-01 - Children Claritin Allergy

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
11523-4360
Requested NDC
11523-4360-01
Package NDCs from labels
11523-4360-5, 11523-4360-2, 11523-4360-6, 11523-4360-4, 11523-4360-7, 11523-4360-3, 11523-4360-1, 11523-4360-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's Claritin Allergy (Grape Flavor)Bayer HealthCare LLC.2025-05-15HUMAN OTC DRUG LABEL
Children's Claritin Allergy (Grape Flavor)Bayer HealthCare LLC.2017-05-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4360-1Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-1Children ClaritinAllergy60 mL in 1 BOTTLESOLUTION6018
11523-4360-2Children ClaritinAllergy120 mL in 1 BOTTLESOLUTION12018
11523-4360-2Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy150 mL in 1 BOTTLESOLUTION15018
11523-4360-4Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-4Children ClaritinAllergy30 mL in 1 BOTTLESOLUTION3018
11523-4360-5Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-5Children ClaritinAllergy240 mL in 1 BOTTLESOLUTION24018
11523-4360-6Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-6Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018
11523-4360-7Children ClaritinAllergy2 in 1 CARTONSOLUTION218
11523-4360-7Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4360CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.]18Current NDC, Legacy NDC, 14 package rows20250519_170061e9-e529-4ff0-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4360-5ML - Milliliter11523-4360a5947025-273d-428e-9bc1-8472d5c4fae912019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE]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 1 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATERite Aid Corporationf08ebf00-a1d7-4a6f-a84f-195d000de53d2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
loratadineLORATADINERite Aid Corporation7b804f66-9323-4119-a856-1e6f082807812026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Kroger Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDKROGER COMPANYfb7326db-3512-45ee-9a9b-48f3ebd8d0c52026-09-02WarningsExact identifier
unii: E4GA8884NN
LoratadineLORATADINEYYBA CORP5a71de5c-a844-9dd4-e063-6294a90af0152026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
BMNP ACIDUM PHOSPHORICUMACIDUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a598949-7941-8c48-e063-6294a90a1d6a2026-08-31WarningsExact identifier
unii: E4GA8884NN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172026-08-30WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-08-28WarningsExact identifier
unii: 7AJO3BO7QN
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
childrens allergy reliefLORATADINEAmazon.com Services LLC74bc9e66-2bd0-457f-b2c4-5b4c6a1e689c2026-08-20WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
unii: 7AJO3BO7QN
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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