FDA.reportPublic FDA data

COLGATE Great Regular Flavor

Product NDC
35000-913
11-digit product format
350000913
Labeler code
35000
Product ID
35000-913_47460974-c56a-4db6-9ebb-5fbdecbbb067
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
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
35000-913-01COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-01COLGATE Great Regular Flavor28 g in 1 TUBEPASTE, DENTIFRICE283
35000-913-04COLGATE Great Regular Flavor4.25 g in 1 POUCHPASTE, DENTIFRICE4.253
35000-913-20COLGATE Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE243
35000-913-30COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-30COLGATE Great Regular Flavor3 in 1 CARTONPASTE, DENTIFRICE33
35000-913-33COLGATE Great Regular Flavor36.8 g in 1 TUBEPASTE, DENTIFRICE36.83
35000-913-33COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor130 g in 1 TUBEPASTE, DENTIFRICE1303
35000-913-48COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-48COLGATE Great Regular Flavor226 g in 1 TUBEPASTE, DENTIFRICE2263
35000-913-58COLGATE Great Regular Flavor70 g in 1 TUBEPASTE, DENTIFRICE703
35000-913-58COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-60COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-64COLGATE Great Regular Flavor181 g in 1 TUBEPASTE, DENTIFRICE1813
35000-913-64COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-69COLGATE Great Regular Flavor113 g in 1 TUBEPASTE, DENTIFRICE1133
35000-913-69COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-79COLGATE Great Regular Flavor79 g in 1 TUBEPASTE, DENTIFRICE793
35000-913-79COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-82COLGATE Great Regular Flavor232 g in 1 TUBEPASTE, DENTIFRICE2323
35000-913-82COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor141 g in 1 TUBEPASTE, DENTIFRICE1413
35000-913-93COLGATE Great Regular Flavor99 g in 1 TUBEPASTE, DENTIFRICE993

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-913COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 26 package rows20241127_730f40f6-6ac6-49bd-888b-c0b5818a03c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % ToothpastePSNf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-913-01350000913011 TUBE in 1 CARTON (35000-913-01) / 28 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-04350000913044.25 g in 1 POUCH (35000-913-04) 4.25 g2005-11-050000-00-00NoNoCurrent
35000-913-203500009132024 g in 1 TUBE (35000-913-20) 24 g2005-11-050000-00-00NoNoCurrent
35000-913-30350000913303 TUBE in 1 CARTON (35000-913-30) / 170 g in 1 TUBE3 tube2005-11-05NoNoCurrent
35000-913-33350000913331 TUBE in 1 CARTON (35000-913-33) > 36.8 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-46350000913461 TUBE in 1 CARTON (35000-913-46) > 130 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-48350000913481 TUBE in 1 CARTON (35000-913-48) / 226 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-58350000913581 TUBE in 1 CARTON (35000-913-58) / 70 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-6035000091360170 g in 1 TUBE (35000-913-60) 170 g2005-11-050000-00-00NoNoCurrent
35000-913-64350000913641 TUBE in 1 CARTON (35000-913-64) > 181 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-69350000913691 TUBE in 1 CARTON (35000-913-69) / 113 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-79350000913791 TUBE in 1 CARTON (35000-913-79) > 79 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-82350000913821 TUBE in 1 CARTON (35000-913-82) > 232 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-92350000913921 TUBE in 1 CARTON (35000-913-92) / 141 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-933500009139399 g in 1 TUBE (35000-913-93) 99 g2005-11-050000-00-00NoNoCurrent