FDA.reportPublic FDA data

COLGATE Great Regular Flavor

Product NDC
65954-060
11-digit product format
659540060
Labeler code
65954
Product ID
65954-060_5fa9c12f-4bfd-42ac-8784-e5f245d63903
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-11-05
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COLGATE Great Regular Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-060-01COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-01COLGATE Great Regular Flavor28 g in 1 TUBEPASTE, DENTIFRICE2813
65954-060-04COLGATE Great Regular Flavor4.25 g in 1 POUCHPASTE, DENTIFRICE4.2513
65954-060-20COLGATE Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE2413
65954-060-30COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE17013
65954-060-30COLGATE Great Regular Flavor3 in 1 CARTONPASTE, DENTIFRICE313
65954-060-33COLGATE Great Regular Flavor36.8 g in 1 TUBEPASTE, DENTIFRICE36.813
65954-060-33COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-46COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-46COLGATE Great Regular Flavor130 g in 1 TUBEPASTE, DENTIFRICE13013
65954-060-48COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-48COLGATE Great Regular Flavor226 g in 1 TUBEPASTE, DENTIFRICE22613
65954-060-58COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-58COLGATE Great Regular Flavor70 g in 1 TUBEPASTE, DENTIFRICE7013
65954-060-60COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE17013
65954-060-64COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-64COLGATE Great Regular Flavor181 g in 1 TUBEPASTE, DENTIFRICE18113
65954-060-69COLGATE Great Regular Flavor113 g in 1 TUBEPASTE, DENTIFRICE11313
65954-060-69COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-79COLGATE Great Regular Flavor79 g in 1 TUBEPASTE, DENTIFRICE7913
65954-060-79COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-82COLGATE Great Regular Flavor232 g in 1 TUBEPASTE, DENTIFRICE23213
65954-060-82COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-92COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE113
65954-060-92COLGATE Great Regular Flavor141 g in 1 TUBEPASTE, DENTIFRICE14113
65954-060-93COLGATE Great Regular Flavor99 g in 1 TUBEPASTE, DENTIFRICE9913

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-060COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]13Current NDC, Legacy NDC, 26 package rows20250110_0ad8745e-f682-4729-8917-15cb590a1226.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN0ad8745e-f682-4729-8917-15cb590a122613
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0ad8745e-f682-4729-8917-15cb590a122613
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0ad8745e-f682-4729-8917-15cb590a122613
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0ad8745e-f682-4729-8917-15cb590a122613
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0ad8745e-f682-4729-8917-15cb590a122613
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0ad8745e-f682-4729-8917-15cb590a122613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-060-01659540060011 TUBE in 1 CARTON (65954-060-01) / 28 g in 1 TUBE1 tube2005-11-05NoNoHistorical
65954-060-04659540060044.25 g in 1 POUCH (65954-060-04) 4.25 g2005-11-05NoNoHistorical
65954-060-206595400602024 g in 1 TUBE (65954-060-20) 24 g2005-11-05NoNoHistorical
65954-060-30659540060303 TUBE in 1 CARTON (65954-060-30) / 170 g in 1 TUBE3 tube2005-11-05NoNoHistorical
65954-060-336595400603336.8 g in 1 TUBE36.8 gHistorical
65954-060-46659540060461 in 1 CARTONHistorical
65954-060-48659540060481 TUBE in 1 CARTON (65954-060-48) / 226 g in 1 TUBE1 tube2005-11-05NoNoHistorical
65954-060-58659540060581 TUBE in 1 CARTON (65954-060-58) / 70 g in 1 TUBE1 tube2005-11-05NoNoHistorical
65954-060-6065954006060170 g in 1 TUBE (65954-060-60) 170 g2005-11-05NoNoHistorical
65954-060-64659540060641 in 1 CARTONHistorical
65954-060-69659540060691 TUBE in 1 CARTON (65954-060-69) / 113 g in 1 TUBE1 tube2005-11-05NoNoHistorical
65954-060-796595400607979 g in 1 TUBE79 gHistorical
65954-060-8265954006082232 g in 1 TUBE232 gHistorical
65954-060-92659540060921 TUBE in 1 CARTON (65954-060-92) / 141 g in 1 TUBE1 tube2005-11-05NoNoHistorical
65954-060-936595400609399 g in 1 TUBE99 gHistorical