MediChoice Fluoride

Product NDC
39892-0602
11-digit product format
398920602
Labeler code
39892
Product ID
39892-0602_40b535d8-2de7-7246-e063-6294a90a7c9b
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
O&M HALYARD, INC.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
7.6 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MediChoice Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a87956fa-8975-4a44-9e9a-4b2191e401feAvailable on FDA.report

DailyMed Package Descriptions#

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

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

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

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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
application number: M021
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
application number: M021
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNa87956fa-8975-4a44-9e9a-4b2191e401fe6
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa87956fa-8975-4a44-9e9a-4b2191e401fe6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa87956fa-8975-4a44-9e9a-4b2191e401fe6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa87956fa-8975-4a44-9e9a-4b2191e401fe6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa87956fa-8975-4a44-9e9a-4b2191e401fe6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa87956fa-8975-4a44-9e9a-4b2191e401fe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0602-13989206020117 g in 1 TUBE (39892-0602-1) 17 g2013-03-010000-00-00NoNoCurrent