FDA.reportPublic FDA data

NDC 39892-0602-01 - MediChoice Fluoride

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
39892-0602
Requested NDC
39892-0602-01
Package NDCs from labels
39892-0602-1, 39892-0602-01
Manufacturer
O&M HALYARD, INC. | Owens & Minor Inc.
Effective date
2025-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MediChoice Fluoride ToothpasteO&M HALYARD, INC. | Owens & Minor Inc.2025-10-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0602-1MediChoice Fluoride17 g in 1 TUBEPASTE, DENTIFRICE176

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0602MEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR INC.]5Current NDC, Legacy NDC, 1 package rows20231213_a87956fa-8975-4a44-9e9a-4b2191e401fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM SILICATEINACTIVE INGREDIENTIJF18F77L3MEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
SORBITOLINACTIVE INGREDIENT506T60A25RMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]1
WATERINACTIVE INGREDIENT059QF0KO0RMEDICHOICE FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [OWENS & MINOR]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 36 of 233 · 4,655 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
unii: 15FIX9V2JP
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
unii: K679OBS311
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
rxcui: 545626
unii: C810JCZ56Q
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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