Home NDC 84516-040-01 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84516-040-01 Cloveden 100 times higher concentrated 50 mL in 1 BOTTLE MOUTHWASH 50 1 84516-040-02 Cloveden 100 times higher concentrated 1 in 1 CARTON MOUTHWASH 1 1
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 55 of 81 · 1,615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Systane COMPLETE PROPYLENE GLYCOL Alcon Laboratories, Inc. 2df0de02-a3e2-471a-9e10-040c3fba75fe 2025-08-08 Warnings Exact identifier unii: 6DC9Q167V3 Durma DynaGel DURMA DYNAGEL Dynarex Corporation 3bcbe314-98ca-78f1-e063-6394a90a13ad 2025-08-07 Warnings Exact identifier unii: PDC6A3C0OX Medics Choice Fresh and Soothe CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN Unimed 3bcd8394-f486-d306-e063-6294a90a4e9a 2025-08-07 Warnings Exact identifier unii: PDC6A3C0OX Systane Balance PROPYLENE GLYCOL Alcon Laboratories, Inc. c7b1a03a-a5f2-409e-a34a-d6f166671de5 2025-08-07 Warnings Exact identifier unii: 6DC9Q167V3 Colgate Total Active Prevention Peppermint CETYLPYRIDINIUM CHLORIDE COLGATE PALMOLIVE COMPANY ac699126-9e95-b2d9-637b-961acb441938 2025-08-04 Warnings Exact identifier unii: D9OM4SK49P Medics Choice Fresh and Soothe CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN KC Pharmaceuticals, Inc. 3bc03d54-6b31-5921-e063-6294a90af599 2025-08-01 Warnings Exact identifier unii: PDC6A3C0OX Systane Ultra POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL Alcon Laboratories, Inc. 0537c23a-15f7-be64-1231-a6c93468e9a8 2025-07-30 Warnings Exact identifier unii: 6DC9Q167V3 Systane POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL Alcon Laboratories, Inc. 1d679d0f-cec2-a644-79cd-079607254bb9 2025-07-30 Warnings Exact identifier unii: 6DC9Q167V3 Systane Ultra Preservative Free POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL Alcon Laboratories, Inc. 751fb85f-6683-4b0a-a650-324d4a74c5de 2025-07-30 Warnings Exact identifier unii: 6DC9Q167V3 Systane COMPLETE PF PROPYLENE GLYCOL Alcon Laboratories, Inc. 99b63d62-1cf0-4f28-8760-773917c2538a 2025-07-29 Warnings Exact identifier unii: 6DC9Q167V3 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 Doctor Butler Hemorrhoid and Fissure Advanced Formula GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5% Beyond Health, PA d2a769e2-afd0-aed2-e053-2995a90ad429 2025-07-23 Warnings Exact identifier unii: PDC6A3C0OX ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Cold Sore Fast-Acting Pain Relief GLYCERIN AND LIDOCAINE Blistex Inc. c7511322-dd6c-441c-bf7d-ad4f0c14956a 2025-07-22 Warnings Exact identifier unii: PDC6A3C0OX Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier unii: PDC6A3C0OX unii: D9OM4SK49P
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.