NDC 84516-040-01 - Cloveden 100 times higher concentrated

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
84516-040
Requested NDC
84516-040-01
Package NDCs from labels
84516-040-01, 84516-040-02
Manufacturer
Acuseplanet Inc | DONG IL PHARMS CO., LTD.
Effective date
2025-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetylpyridinium Chloride - Acuseplanet Inc | DONG IL PHARMS CO., LTD.Acuseplanet Inc | DONG IL PHARMS CO., LTD.2025-08-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84516-040-01Cloveden 100 times higher concentrated50 mL in 1 BOTTLEMOUTHWASH501
84516-040-02Cloveden 100 times higher concentrated1 in 1 CARTONMOUTHWASH11

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 13 of 81 · 1,615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Cepacol AntibacterialCETYLPYRIDINIUM CHLORIDEReckitt Benckiser LLC7c19eba6-3ebd-497f-9066-6152b72eafdd2026-05-13WarningsExact identifier
unii: D9OM4SK49P
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Alcohol FreeCETYLPYRIDINIUM CLORIDEH E B9787c416-e2c6-49f9-817f-ef1df38575832026-05-05Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P

Reported adverse events (FAERS/openFDA)#

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