FDA.reportPublic FDA data

Freshmint Anticavity Fluoride

Product NDC
51824-068
11-digit product format
518240068
Labeler code
51824
Product ID
51824-068_5ce1342b-1b8b-080f-e063-6294a90ae9d2
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
New World Imports, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-17
Substance
SODIUM FLUORIDE
Active strength
2.2 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 Anticavity Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.2 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
51824-068-01Freshmint Anticavity Fluoride7.9 g in 1 PACKETGEL, DENTIFRICE7.93
51824-068-02Freshmint Anticavity Fluoride17 g in 1 TUBEGEL, DENTIFRICE173
51824-068-03Freshmint Anticavity Fluoride24 g in 1 TUBEGEL, DENTIFRICE243
51824-068-04Freshmint Anticavity Fluoride43 g in 1 TUBEGEL, DENTIFRICE433
51824-068-05Freshmint Anticavity Fluoride78 g in 1 TUBEGEL, DENTIFRICE783
51824-068-06Freshmint Anticavity Fluoride130 g in 1 TUBEGEL, DENTIFRICE1303
51824-068-07Freshmint Anticavity Fluoride181 g in 1 TUBEGEL, DENTIFRICE1813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-068FRESHMINT ANTICAVITY FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [NEW WORLD IMPORTS, INC]3Current NDC, Legacy NDC, 7 package rows20241109_2fa21cac-e71e-4bda-93ac-b5672d2d5095.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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN2fa21cac-e71e-4bda-93ac-b5672d2d50953
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2fa21cac-e71e-4bda-93ac-b5672d2d50953
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2fa21cac-e71e-4bda-93ac-b5672d2d50953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-068-01518240068017.9 g in 1 PACKET (51824-068-01) 7.9 g2010-09-170000-00-00NoNoCurrent
51824-068-025182400680217 g in 1 TUBE (51824-068-02) 17 g2010-09-170000-00-00NoNoCurrent
51824-068-035182400680324 g in 1 TUBE (51824-068-03) 24 g2010-09-170000-00-00NoNoCurrent
51824-068-045182400680443 g in 1 TUBE (51824-068-04) 43 g2010-09-170000-00-00NoNoCurrent
51824-068-055182400680578 g in 1 TUBE (51824-068-05) 78 g2010-09-170000-00-00NoNoCurrent
51824-068-0651824006806130 g in 1 TUBE (51824-068-06) 130 g2010-09-170000-00-00NoNoCurrent
51824-068-0751824006807181 g in 1 TUBE (51824-068-07) 181 g2010-09-170000-00-00NoNoCurrent