FDA.reportPublic FDA data

Colgate MaxFresh Knockout

Product NDC
35000-214
11-digit product format
350000214
Labeler code
35000
Product ID
35000-214_b42397a1-032c-4357-8db0-2fe749e20153
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
SODIUM FLUORIDE
Active strength
1.1 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 MaxFresh Knockout
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-214-30Colgate MaxFresh Knockout3 in 1 CELLO PACKGEL, DENTIFRICE31
35000-214-30Colgate MaxFresh Knockout1 in 1 CARTONGEL, DENTIFRICE11
35000-214-95Colgate MaxFresh Knockout178 g in 1 TUBEGEL, DENTIFRICE1781
35000-214-95Colgate MaxFresh Knockout1 in 1 CARTONGEL, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-214COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 4 package rows20250204_0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN0ffbb3a9-7bfa-4f6a-aef3-fde327a410c91
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD0ffbb3a9-7bfa-4f6a-aef3-fde327a410c91
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY0ffbb3a9-7bfa-4f6a-aef3-fde327a410c91
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY0ffbb3a9-7bfa-4f6a-aef3-fde327a410c91
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY0ffbb3a9-7bfa-4f6a-aef3-fde327a410c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-214-30350000214303 CARTON in 1 CELLO PACK (35000-214-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2025-02-03NoNoCurrent
35000-214-95350000214951 TUBE in 1 CARTON (35000-214-95) / 178 g in 1 TUBE1 tube2025-02-03NoNoCurrent