FDA.reportPublic FDA data

Colgate Triple Action

Product NDC
65954-536
11-digit product format
659540536
Labeler code
65954
Product ID
65954-536_88022c4f-fcab-4950-b2b2-72c336096b8a
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-01
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Triple Action
Listing expiration
2027-12-31

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
65954-536-30Colgate Triple Action3 in 1 CARTONPASTE, DENTIFRICE318
65954-536-30Colgate Triple Action170 g in 1 TUBEPASTE, DENTIFRICE17018
65954-536-46Colgate Triple Action130 g in 1 TUBEPASTE, DENTIFRICE13018
65954-536-46Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-47Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-47Colgate Triple Action133 g in 1 TUBEPASTE, DENTIFRICE13318
65954-536-48Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-48Colgate Triple Action226 g in 1 TUBEPASTE, DENTIFRICE22618
65954-536-58Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-58Colgate Triple Action70 g in 1 TUBEPASTE, DENTIFRICE7018
65954-536-60Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-60Colgate Triple Action170 g in 1 TUBEPASTE, DENTIFRICE17018
65954-536-63Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-63Colgate Triple Action85 g in 1 TUBEPASTE, DENTIFRICE8518
65954-536-64Colgate Triple Action181 g in 1 TUBEPASTE, DENTIFRICE18118
65954-536-64Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-69Colgate Triple Action113 g in 1 TUBEPASTE, DENTIFRICE11318
65954-536-69Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-79Colgate Triple Action79 g in 1 TUBEPASTE, DENTIFRICE7918
65954-536-79Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-82Colgate Triple Action232 g in 1 TUBEPASTE, DENTIFRICE23218
65954-536-82Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-92Colgate Triple Action141 g in 1 TUBEPASTE, DENTIFRICE14118
65954-536-92Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-99Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE118
65954-536-99Colgate Triple Action99 g in 1 TUBEPASTE, DENTIFRICE9918

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-536COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]16Current NDC, Legacy NDC, 26 package rows20241128_85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb418
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb418
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb418
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb418
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-536-30659540536303 TUBE in 1 CARTON (65954-536-30) / 170 g in 1 TUBE3 tube2025-01-01NoNoHistorical
65954-536-4665954053646130 g in 1 TUBE130 gHistorical
65954-536-47659540536471 in 1 CARTONHistorical
65954-536-48659540536481 TUBE in 1 CARTON (65954-536-48) / 226 g in 1 TUBE1 tube2010-12-01NoNoHistorical
65954-536-58659540536581 TUBE in 1 CARTON (65954-536-58) / 70 g in 1 TUBE1 tube2010-12-01NoNoHistorical
65954-536-60659540536601 TUBE in 1 CARTON (65954-536-60) / 170 g in 1 TUBE1 tube2010-12-01NoNoHistorical
65954-536-63659540536631 in 1 CARTONHistorical
65954-536-6465954053664181 g in 1 TUBE181 gHistorical
65954-536-69659540536691 TUBE in 1 CARTON (65954-536-69) / 113 g in 1 TUBE1 tube2010-12-01NoNoHistorical
65954-536-796595405367979 g in 1 TUBE79 gHistorical
65954-536-8265954053682232 g in 1 TUBE232 gHistorical
65954-536-9265954053692141 g in 1 TUBE141 gHistorical
65954-536-99659540536991 in 1 CARTONHistorical