FDA.reportPublic FDA data

NDC 11523-4364-01 - Claritin Chewable Cool Mint Flavor

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
11523-4364
Requested NDC
11523-4364-01
Package NDCs from labels
11523-4364-1, 11523-4364-2, 11523-4364-3, 11523-4364-5, 11523-4364-6, 11523-4364-7, 11523-4364-4, 11523-4364-01
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 10mg Cool Mint Chewable (1613932)Bayer HealthCare LLC.2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4364-1Claritin ChewableCool Mint Flavor3 in 1 CARTONTABLET, CHEWABLE35
11523-4364-1Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-2Claritin ChewableCool Mint Flavor2 in 1 BLISTER PACKTABLET, CHEWABLE25
11523-4364-2Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-3Claritin ChewableCool Mint Flavor4 in 1 BLISTER PACKTABLET, CHEWABLE45
11523-4364-3Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-4Claritin ChewableCool Mint Flavor7 in 1 CARTONTABLET, CHEWABLE75
11523-4364-4Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-5Claritin ChewableCool Mint Flavor8 in 1 CARTONTABLET, CHEWABLE85
11523-4364-5Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-6Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-6Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-7Claritin ChewableCool Mint Flavor2 in 1 BLISTER PACKTABLET, CHEWABLE25
11523-4364-7Claritin ChewableCool Mint Flavor1 in 1 POUCHTABLET, CHEWABLE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4364CLARITIN CHEWABLE COOL MINT FLAVOR (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]4Current NDC, Legacy NDC, 14 package rows20231214_98b99bb9-d499-9ab4-e053-2a95a90a6ae6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4364-1EA - Each11523-4364a888024d-d3f7-43cb-9107-b6e9040b6de012025-05-14

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 2 of 168 · 3,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
unii: L7T10EIP3A
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172026-08-30WarningsExact identifier
unii: 7AJO3BO7QN
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Rhinoost SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a296baa-c101-3192-e063-6394a90aa2b02026-08-29WarningsExact identifier
unii: L7T10EIP3A
LUCKSKY SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a29ee19-8b6d-b4fa-e063-6394a90ad81d2026-08-29WarningsExact identifier
unii: L7T10EIP3A
Flobow SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a2aa169-90b5-417f-e063-6394a90aa2782026-08-29WarningsExact identifier
unii: L7T10EIP3A
Hoxlbin SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a17b116-d573-1c4a-e063-6394a90a499b2026-08-28WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Unikinesys SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a275076-b75a-7d2c-e063-6294a90ad2222026-08-28WarningsExact identifier
unii: L7T10EIP3A
TideFresh SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a27a35c-8c6b-d298-e063-6294a90a13892026-08-28WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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