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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINTSODIUM FLUORIDEColgate-Palmolive Company9aaa451d-8827-41b7-9661-bc1a7a69cfc32026-06-30WarningsExact identifier
application number: M021
CrestPlus Deep Clean plus Whitening Effervescent MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5579be77-97df-1000-e063-6294a90a47252026-06-30WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTHSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company358842de-3e1d-4f66-8d08-fe8538441b342026-06-29WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited5356d0a8-2db4-ce7f-e063-6394a90aa6d22026-06-26WarningsExact identifier
application number: M021
Colgate Optic White Renewal Brilliant ShineSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company70734d67-fc3e-4515-b6e6-ab2c466578d62026-06-26WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Companyf87d6f04-507a-47ae-8a66-204cf59261c02026-06-26WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513ba92-cadc-2cf3-e063-6294a90ac3e52026-06-25WarningsExact identifier
application number: M021
Crest Plus Active Fresh Scope plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513e40f-b8e8-2d9a-e063-6394a90ab1702026-06-25WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Mint SplashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6c690e-a1bb-4606-e063-6394a90ac4b62026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bbc3d-a1f9-b278-e063-6294a90a62f72026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bd56c-dac8-eb87-e063-6294a90a3cc12026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0b1d46-d52c-f409-e063-6394a90a55742026-06-25Exact identifier
application number: M021
Crest Plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5514e09e-0a7d-93e6-e063-6294a90ae3f02026-06-25WarningsExact identifier
application number: M021
Colgate Sparkling White Mint ZingSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company0c2fe62b-4905-4213-a85b-e073d8eeb7412026-06-24WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Company890c4c29-bba8-4775-a053-10c6292df9302026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55004d9d-eda7-a285-e063-6294a90ad4ca2026-06-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.5500686c-d417-c50a-e063-6294a90ac7fa2026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5500f9ab-b0c4-51d6-e063-6394a90acd382026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5504ec96-aae1-f5f9-e063-6294a90ad8bb2026-06-24WarningsExact identifier
application number: M021
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact 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