MediChoice Premium Anticavity Fluoride

Product NDC
39892-0603
11-digit product format
398920603
Labeler code
39892
Product ID
39892-0603_40b23569-3539-20aa-e063-6394a90ae6ea
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
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 FLUORIDE
Active strength
2.43 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 Premium Anticavity Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.43 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6ba9b51-b958-4836-adc8-871529a43fc6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0603-2MediChoice Premium Anticavity Fluoride24 g in 1 TUBEPASTE, DENTIFRICE246

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
SORBITOLINACTIVE INGREDIENT506T60A25RMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1
WATERINACTIVE INGREDIENT059QF0KO0RMEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0603MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]5Current NDC, Legacy NDC, 1 package rows20231213_c6ba9b51-b958-4836-adc8-871529a43fc6.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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc5d5bc17-e81b-34aa-e053-2a95a90ad77f2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance BlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d9a1754-8d38-054f-e053-2991aa0a46532026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNc6ba9b51-b958-4836-adc8-871529a43fc66
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDc6ba9b51-b958-4836-adc8-871529a43fc66
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYc6ba9b51-b958-4836-adc8-871529a43fc66
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYc6ba9b51-b958-4836-adc8-871529a43fc66
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYc6ba9b51-b958-4836-adc8-871529a43fc66
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYc6ba9b51-b958-4836-adc8-871529a43fc66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0603-23989206030224 g in 1 TUBE (39892-0603-2) 24 g2013-03-010000-00-00NoNoCurrent