FDA.reportPublic FDA data

Freshmint Premium Anticavity

Product NDC
51824-034
11-digit product format
518240034
Labeler code
51824
Product ID
51824-034_5ce0ef40-69ff-69cf-e063-6294a90a8b6e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
New World Imports, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-04
Substance
SODIUM FLUORIDE
Active strength
2.43 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Freshmint Premium Anticavity
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-034-01Freshmint Premium Anticavity130 g in 1 TUBEPASTE, DENTIFRICE1307
51824-034-09Freshmint Premium Anticavity8 g in 1 PACKETPASTE, DENTIFRICE87

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RFRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-034FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]5Current NDC, Legacy NDC, 2 package rows20250423_1a42cf2d-6c48-4e38-97bc-b6f2084bf39b.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 30 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPasteOne Kids Blue RaspberryMI PASTE ONE KIDS BLUE RASPBERRYGC America Inc.bf7d668c-752a-2eee-e053-2a95a90add162025-12-19WarningsExact identifier
application number: M021
MIPaste Plus Tutti FruttiMIPASTE PLUS TUTTI FRUTTIGC America Inc.d724bd2a-2a8e-faeb-e053-2995a90aca192025-12-19WarningsExact identifier
application number: M021
MIPaste Plus VanillaMIPASTE PLUS VANILLAGC America Inc.d7244125-1ca5-78ba-e053-2995a90ab7642025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MelonMIPASTE PLUS MELONGC America Inc.d724fe9f-c9ef-d9ad-e053-2995a90a7ecf2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MintMIPASTE PLUS MINTGC America Inc.d72415b3-c501-141f-e053-2995a90aaaa32025-12-19WarningsExact identifier
application number: M021
MIPaste One PerioMIPASTE ONE PERIOGC America Inc.d656b72d-48f8-4425-e053-2995a90ab1f22025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Blue RaspberryMIPASTE ONE KIDS BLUE RASPBERRYGC America Inc.c07e1058-903b-fd47-e053-2995a90afdab2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus StrawberryMIPASTE PLUS STRAWBERRYGC America Inc.d7235ad7-83d7-12e5-e053-2a95a90aaeaf2025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Cotton CandyMIPASTE ONE KIDS COTTON CANDYGC America Inc.c07d6b50-1d67-ea7f-e053-2a95a90afbe42025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Bubble GumMIPASTE ONE KIDS BUBBLE GUMGC America Inc.c07c7853-763b-4383-e053-2995a90ab7252025-12-19WarningsExact identifier
application number: M021
MIPaste OneMIPASTE ONEGC America Inc.d71f8e6e-7005-4b3e-e053-2995a90a67892025-12-19WarningsExact identifier
application number: M021
TheraBreath AM-PM Twin PackSODIUM FLUORIDEChurch & Dwight Co., Inc.4618e390-9039-a1d0-e063-6294a90ab2942025-12-16WarningsExact identifier
application number: M021
Parodontax Gum Strengthen and ProtectSTANNOUS FLUORIDEHaleon US Holdings LLC3bb40ceb-841b-4a25-e063-6294a90ab8972025-12-15WarningsExact identifier
application number: M021
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1a42cf2d-6c48-4e38-97bc-b6f2084bf39b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-034-0151824003401130 g in 1 TUBE (51824-034-01) 130 g2013-04-040000-00-00NoNoCurrent
51824-034-09518240034098 g in 1 PACKET (51824-034-09) 8 g2016-09-010000-00-00NoNoCurrent