FDA.reportPublic FDA data

Colgate MaxFresh Knockout

Product NDC
35000-127
11-digit product format
350000127
Labeler code
35000
Product ID
35000-127_aa4c35c1-54b0-42a0-abec-a41932c0821c
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
2019-10-24
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 Knockout

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
35000-127-30Colgate MaxFresh Knockout1 in 1 CARTONPASTE, DENTIFRICE114
35000-127-30Colgate MaxFresh Knockout3 in 1 CELLO PACKPASTE, DENTIFRICE314
35000-127-60Colgate MaxFresh Knockout170 g in 1 TUBEPASTE, DENTIFRICE17014
35000-127-60Colgate MaxFresh Knockout1 in 1 CARTONPASTE, DENTIFRICE114
35000-127-74Colgate MaxFresh Knockout1 in 1 CARTONPASTE, DENTIFRICE114
35000-127-74Colgate MaxFresh Knockout182 g in 1 TUBEPASTE, DENTIFRICE18214
35000-127-95Colgate MaxFresh Knockout178 g in 1 TUBEPASTE, DENTIFRICE17814
35000-127-95Colgate MaxFresh Knockout1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-127COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]13Current NDC, Legacy NDC, 8 package rows20241115_b6ca4ec7-5087-4693-82b7-199b44d7f931.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNb6ca4ec7-5087-4693-82b7-199b44d7f93114
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDb6ca4ec7-5087-4693-82b7-199b44d7f93114
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYb6ca4ec7-5087-4693-82b7-199b44d7f93114
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYb6ca4ec7-5087-4693-82b7-199b44d7f93114
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYb6ca4ec7-5087-4693-82b7-199b44d7f93114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-127-30350000127303 CARTON in 1 CELLO PACK (35000-127-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2023-07-242026-12-30NoNoHistorical
35000-127-60350000127601 TUBE in 1 CARTON (35000-127-60) > 170 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent
35000-127-74350000127741 TUBE in 1 CARTON (35000-127-74) > 182 g in 1 TUBE1 tube2020-06-232022-12-31NoNoCurrent
35000-127-95350000127951 TUBE in 1 CARTON (35000-127-95) / 178 g in 1 TUBE1 tube2021-12-012026-12-30NoNoCurrent