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 4 of 168 · 3,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
unii: L7T10EIP3A
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
unii: L7T10EIP3A
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
unii: L7T10EIP3A
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
unii: L7T10EIP3A
SC HERBALMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLCb79b6f57-d062-4c6d-ade8-dfa841c6bf0f2026-08-20WarningsExact identifier
unii: L7T10EIP3A
childrens allergy reliefLORATADINEAmazon.com Services LLC74bc9e66-2bd0-457f-b2c4-5b4c6a1e689c2026-08-20WarningsExact identifier
unii: 7AJO3BO7QN
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
unii: L7T10EIP3A
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
unii: 7AJO3BO7QN
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
unii: L7T10EIP3A
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC5965eb2a-1261-5258-e063-6294a90a7c2d2026-08-19WarningsExact identifier
unii: L7T10EIP3A
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
unii: L7T10EIP3A
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
unii: L7T10EIP3A
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
unii: L7T10EIP3A
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
unii: L7T10EIP3A
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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