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 8 of 168 · 3,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
unii: L7T10EIP3A
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
unii: L7T10EIP3A
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
unii: L7T10EIP3A
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
unii: L7T10EIP3A
Green bud SOOTHING MASSAGE FLUIDGREEN BUD SOOTHING MASSAGE FLUIDWANWANG INC57b01b7b-0ea9-f8c9-e063-6394a90a95c62026-07-28WarningsExact identifier
unii: L7T10EIP3A
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
unii: L7T10EIP3A
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
unii: L7T10EIP3A
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
unii: L7T10EIP3A
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
unii: L7T10EIP3A
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
unii: L7T10EIP3A
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
unii: L7T10EIP3A
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
unii: L7T10EIP3A
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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