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 147 of 227 · 4,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Tums Chewy Bites Orange and Cream ESCALCIUM CARBONATEHaleon US Holdings LLC036ef1ed-32ef-46b8-8817-b3f63a0142802025-02-14WarningsExact identifier
unii: H0G9379FGK
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
unii: 15FIX9V2JP
Tums NaturalsCALCIUM CARBONATEHaleon US Holdings LLCd8da54b8-6456-4e7d-acd2-a55e2249bd012025-02-13WarningsExact identifier
unii: H0G9379FGK
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEHarris Teeter, LLC2cb4c58f-ee88-b60e-e063-6294a90a1e6c2025-02-12WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid PeppermintCALCIUM CARBONATEHarris Teeter, LLC2cb54a40-98ce-2660-e063-6294a90a3ed02025-02-11WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEHarris Teeter, LLC2c65f7f5-195c-ed33-e063-6294a90a30702025-02-11WarningsExact identifier
unii: H0G9379FGK
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021
SILICEA 6XSILICEASEVENE USAff0e0009-8bbe-e0eb-e053-6294a90afa822025-02-11WarningsExact identifier
unii: ETJ7Z6XBU4
Regular Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb50083-b05f-8aca-e063-6394a90a6d6f2025-02-11WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2c544c08-8cdb-edf2-e063-6394a90a024c2025-02-11WarningsExact identifier
unii: H0G9379FGK
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 200ckSILICEASEVENE USAcf89bb22-9e2f-9143-e053-2995a90aff192025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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