FDA.reportPublic FDA data

NDC 84516-010-01 - Cloveden Tooth

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
84516-010
Requested NDC
84516-010-01
Package NDCs from labels
84516-010-01, 84516-010-02
Manufacturer
Acuseplanet Inc | DONG IL PHARMS CO., LTD.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cloveden Tooth - Acuseplanet Inc | DONG IL PHARMS CO., LTD.Acuseplanet Inc | DONG IL PHARMS CO., LTD.2024-07-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84516-010-01Cloveden Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
84516-010-02Cloveden Tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84516-010CLOVEDEN TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ACUSEPLANET INC]12 package rows20240718_1d6d6d7b-4a9f-901a-e063-6394a90a7d39.zip

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 24 of 33 · 656 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
rxcui: 545626
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
rxcui: 545626
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
rxcui: 545626
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
rxcui: 545626
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
rxcui: 545626
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
rxcui: 545626
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
rxcui: 545626
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
rxcui: 545626
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
rxcui: 545626
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
rxcui: 545626
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
unii: C810JCZ56Q
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
unii: C810JCZ56Q
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
rxcui: 545626
unii: C810JCZ56Q
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
rxcui: 545626
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
unii: PDC6A3C0OX
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
rxcui: 545626
unii: C810JCZ56Q

Reported adverse events (FAERS/openFDA)#

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