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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact 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