FDA.reportPublic FDA data

NDC 11523-4364-04 - 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
11523-4364-04
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, 11523-4364-04
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 1 of 171 · 3,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact identifier
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
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
unii: L7T10EIP3A
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
unii: L7T10EIP3A
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
unii: L7T10EIP3A
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
unii: L7T10EIP3A
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: L7T10EIP3A
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
unii: L7T10EIP3A
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

Reported adverse events (FAERS/openFDA)#

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