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 108 of 229 · 4,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICECALCIUM CARBONATEQUALITY CHOICE (Chain drug Marketing Assoiciation)9ff282fd-7623-4c9e-8faa-c51e33a7616e2025-12-04WarningsExact identifier
unii: H0G9379FGK
QUALITY CHOICE Extra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)7c948dc6-e569-46d2-8edd-59da48857e0e2025-12-04WarningsExact identifier
unii: H0G9379FGK
QUALITY CHOICE Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)b074a885-5d10-46e4-8de9-dd9460968dad2025-12-04WarningsExact identifier
unii: H0G9379FGK
Quality Choice Extra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)2bb8ccb6-6275-4ace-8096-ee545501df392025-12-04WarningsExact identifier
unii: H0G9379FGK
Quality Choice Ultra StrengthANTACID TABLET (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)cdac56f1-e579-4943-a24a-6564c30086d22025-12-04WarningsExact identifier
unii: H0G9379FGK
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
Alka-Seltzer Heartburn Relief PeppermintCALCIUM CARBONATEBayer HealthCare LLC.9b8e802f-91b6-4559-e053-2a95a90aff672025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Cool Action Heartburn Relief MintCALCIUM CARBONATEBayer HealthCare LLC.9b8da147-8d0c-e6b0-e053-2a95a90a35e62025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.84771ac5-ad0b-e0ec-e053-2a91aa0a1b362025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.bdb43d3b-ddcd-4359-a174-a5556e7c5f572025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Ultra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.7857c357-38cb-2f61-e053-2991aa0a66022025-12-04WarningsExact identifier
unii: H0G9379FGK
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
unii: H0G9379FGK
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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