FDA.reportPublic FDA data

Colgate MaxFresh with Mini Breath Clean Mint

Product NDC
35000-013
11-digit product format
350000013
Labeler code
35000
Product ID
35000-013_e6c8cb12-5fdc-4a5d-855e-e68e1f156b17
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
2013-10-11
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 Clean 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
35000-013-30Colgate MaxFresh with Mini Breath Clean Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-013-30Colgate MaxFresh with Mini Breath Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE318
35000-013-34Colgate MaxFresh with Mini Breath Clean Mint170 g in 1 TUBEPASTE, DENTIFRICE17018
35000-013-34Colgate MaxFresh with Mini Breath Clean Mint2 in 1 CARTONPASTE, DENTIFRICE218
35000-013-60Colgate MaxFresh with Mini Breath Clean Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-013-60Colgate MaxFresh with Mini Breath Clean Mint170 g in 1 TUBEPASTE, DENTIFRICE17018
35000-013-74Colgate MaxFresh with Mini Breath Clean Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-013-74Colgate MaxFresh with Mini Breath Clean Mint182 g in 1 TUBEPASTE, DENTIFRICE18218
35000-013-78Colgate MaxFresh with Mini Breath Clean Mint221 g in 1 TUBEPASTE, DENTIFRICE22118
35000-013-78Colgate MaxFresh with Mini Breath Clean Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-013-95Colgate MaxFresh with Mini Breath Clean Mint1 in 1 CARTONPASTE, DENTIFRICE118
35000-013-95Colgate MaxFresh with Mini Breath Clean Mint178 g in 1 TUBEPASTE, DENTIFRICE17818
35000-013-97Colgate MaxFresh with Mini Breath Clean Mint2 in 1 CARTONPASTE, DENTIFRICE218
35000-013-97Colgate MaxFresh with Mini Breath Clean Mint178 g in 1 TUBEPASTE, DENTIFRICE17818

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Fluoride IonACTIVE MOIETYQ80VPU408OCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Methylcellulose (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Polyethylene Glycol 600INACTIVE INGREDIENTNL4J9F21N9COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
Sodium PyrophosphateINACTIVE INGREDIENTO352864B8ZCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
SorbitolINACTIVE INGREDIENT506T60A25RCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1
WaterINACTIVE INGREDIENT059QF0KO0RCOLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-013COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]17Current NDC, Legacy NDC, 14 package rows20241116_82bc1101-84d7-4e21-be9c-870ad88a4b7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN82bc1101-84d7-4e21-be9c-870ad88a4b7c18
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD82bc1101-84d7-4e21-be9c-870ad88a4b7c18
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY82bc1101-84d7-4e21-be9c-870ad88a4b7c18
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY82bc1101-84d7-4e21-be9c-870ad88a4b7c18
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY82bc1101-84d7-4e21-be9c-870ad88a4b7c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-013-30350000013303 CARTON in 1 CELLO PACK (35000-013-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2023-07-242026-12-30NoNoHistorical
35000-013-34350000013342 TUBE in 1 CARTON (35000-013-34) > 170 g in 1 TUBE2 tube2013-10-110000-00-00NoNoCurrent
35000-013-60350000013601 TUBE in 1 CARTON (35000-013-60) > 170 g in 1 TUBE1 tube2013-10-110000-00-00NoNoCurrent
35000-013-74350000013741 TUBE in 1 CARTON (35000-013-74) > 182 g in 1 TUBE1 tube2020-06-190000-00-00NoNoCurrent
35000-013-78350000013781 TUBE in 1 CARTON (35000-013-78) > 221 g in 1 TUBE1 tube2013-10-112022-12-31NoNoCurrent
35000-013-95350000013951 TUBE in 1 CARTON (35000-013-95) / 178 g in 1 TUBE1 tube2021-12-012026-12-30NoNoCurrent
35000-013-97350000013972 TUBE in 1 CARTON (35000-013-97) / 178 g in 1 TUBE2 tube2022-10-172026-12-30NoNoCurrent