FDA.reportPublic FDA data

Colgate MaxFresh with Mini Breath Cool Mint

Product NDC
35000-014
11-digit product format
350000014
Labeler code
35000
Product ID
35000-014_c2c7cdc5-c563-4f4b-a439-ed0d64cd753d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-23
Marketing end
2026-12-30
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate MaxFresh with Mini Breath Cool Mint

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-014-01Colgate MaxFresh with Mini Breath Cool Mint28 g in 1 TUBEPASTE, DENTIFRICE2818
35000-014-01Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-30Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-30Colgate MaxFresh with Mini Breath Cool Mint3 in 1 CELLO PACKPASTE, DENTIFRICE318
35000-014-34Colgate MaxFresh with Mini Breath Cool Mint2 in 1 CARTONPASTE, DENTIFRICE218
35000-014-34Colgate MaxFresh with Mini Breath Cool Mint170 g in 1 TUBEPASTE, DENTIFRICE17018
35000-014-60Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-60Colgate MaxFresh with Mini Breath Cool Mint170 g in 1 TUBEPASTE, DENTIFRICE17018
35000-014-70Colgate MaxFresh with Mini Breath Cool Mint215 g in 1 TUBEPASTE, DENTIFRICE21518
35000-014-70Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-73Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-73Colgate MaxFresh with Mini Breath Cool Mint206 g in 1 TUBEPASTE, DENTIFRICE20618
35000-014-74Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-74Colgate MaxFresh with Mini Breath Cool Mint182 g in 1 TUBEPASTE, DENTIFRICE18218
35000-014-78Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-78Colgate MaxFresh with Mini Breath Cool Mint215 g in 1 TUBEPASTE, DENTIFRICE21518
35000-014-79Colgate MaxFresh with Mini Breath Cool Mint70 g in 1 TUBEPASTE, DENTIFRICE7018
35000-014-79Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-95Colgate MaxFresh with Mini Breath Cool Mint178 g in 1 TUBEPASTE, DENTIFRICE17818
35000-014-95Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-014-97Colgate MaxFresh with Mini Breath Cool Mint178 g in 1 TUBEPASTE, DENTIFRICE17818
35000-014-97Colgate MaxFresh with Mini Breath Cool Mint2 in 1 CARTONPASTE, DENTIFRICE218
35000-014-99Colgate MaxFresh with Mini Breath Cool Mint53 g in 1 TUBEPASTE, DENTIFRICE5318
35000-014-99Colgate MaxFresh with Mini Breath Cool Mint1 in 1 CARTONPASTE, DENTIFRICE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-014COLGATE MAXFRESH WITH MINI BREATH COOL MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]17Current NDC, Legacy NDC, 24 package rows20240112_51abd6bc-7a3d-4b0e-a810-af9e94926438.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN51abd6bc-7a3d-4b0e-a810-af9e9492643818
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD51abd6bc-7a3d-4b0e-a810-af9e9492643818
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY51abd6bc-7a3d-4b0e-a810-af9e9492643818
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY51abd6bc-7a3d-4b0e-a810-af9e9492643818
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY51abd6bc-7a3d-4b0e-a810-af9e9492643818
416783sodium fluoride 0.24 % ToothpastePSN34c56439-83d4-2808-e054-00144ff88e883
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD34c56439-83d4-2808-e054-00144ff88e883
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY34c56439-83d4-2808-e054-00144ff88e883
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY34c56439-83d4-2808-e054-00144ff88e883
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY34c56439-83d4-2808-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-014-01350000014011 TUBE in 1 CARTON (35000-014-01) > 28 g in 1 TUBE1 tube2013-09-230000-00-00NoNoCurrent
35000-014-30350000014303 CARTON in 1 CELLO PACK (35000-014-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2023-04-132026-12-30NoNoHistorical
35000-014-34350000014342 TUBE in 1 CARTON (35000-014-34) > 170 g in 1 TUBE2 tube2013-09-232024-12-31NoNoCurrent
35000-014-60350000014601 TUBE in 1 CARTON (35000-014-60) > 170 g in 1 TUBE1 tube2013-09-230000-00-00NoNoCurrent
35000-014-70350000014701 TUBE in 1 CARTON (35000-014-70) > 215 g in 1 TUBE1 tube2016-11-302022-12-31NoNoCurrent
35000-014-73350000014731 TUBE in 1 CARTON (35000-014-73) / 206 g in 1 TUBE1 tube2022-01-102026-12-30NoNoCurrent
35000-014-74350000014741 TUBE in 1 CARTON (35000-014-74) > 182 g in 1 TUBE1 tube2020-06-222024-06-30NoNoCurrent
35000-014-78350000014781 TUBE in 1 CARTON (35000-014-78) > 215 g in 1 TUBE1 tube2013-09-230000-00-00NoNoCurrent
35000-014-79350000014791 TUBE in 1 CARTON (35000-014-79) > 70 g in 1 TUBE1 tube2013-09-230000-00-00NoNoCurrent
35000-014-95350000014951 TUBE in 1 CARTON (35000-014-95) / 178 g in 1 TUBE1 tube2021-12-012026-12-30NoNoCurrent
35000-014-97350000014972 TUBE in 1 CARTON (35000-014-97) / 178 g in 1 TUBE2 tube2022-10-172026-12-30NoNoCurrent
35000-014-99350000014991 TUBE in 1 CARTON (35000-014-99) > 53 g in 1 TUBE1 tube2013-09-232022-12-31NoNoCurrent