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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact 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