FDA.reportPublic FDA data

Colgate MaxFresh Charcoal

Product NDC
35000-990
11-digit product format
350000990
Labeler code
35000
Product ID
35000-990_b4307d03-5527-45d0-b2ed-ca82f621c70f
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
2020-10-01
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 MaxFresh Charcoal
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
35000-990-34Colgate MaxFresh Charcoal170 g in 1 TUBEGEL, DENTIFRICE17019
35000-990-34Colgate MaxFresh Charcoal2 in 1 CARTONGEL, DENTIFRICE219
35000-990-58Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-58Colgate MaxFresh Charcoal70.8 g in 1 TUBEGEL, DENTIFRICE70.819
35000-990-60Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-60Colgate MaxFresh Charcoal170 g in 1 TUBEGEL, DENTIFRICE17019
35000-990-69Colgate MaxFresh Charcoal113 g in 1 TUBEGEL, DENTIFRICE11319
35000-990-69Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-95Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-95Colgate MaxFresh Charcoal178 g in 1 TUBEGEL, DENTIFRICE17819
35000-990-99Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-99Colgate MaxFresh Charcoal53.8 g in 1 TUBEGEL, DENTIFRICE53.819

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-990COLGATE MAXFRESH CHARCOAL (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]15Current NDC, Legacy NDC, 12 package rows20241101_890c4c29-bba8-4775-a053-10c6292df930.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-990-34350000990342 TUBE in 1 CARTON (35000-990-34) > 170 g in 1 TUBE2 tube2020-11-160000-00-00NoNoCurrent
35000-990-58350000990581 TUBE in 1 CARTON (35000-990-58) / 70.8 g in 1 TUBE1 tube2020-10-010000-00-00NoNoCurrent
35000-990-60350000990601 TUBE in 1 CARTON (35000-990-60) > 170 g in 1 TUBE1 tube2020-10-240000-00-00NoNoCurrent
35000-990-69350000990691 TUBE in 1 CARTON (35000-990-69) / 113 g in 1 TUBE1 tube2024-06-17NoNoHistorical
35000-990-95350000990951 TUBE in 1 CARTON (35000-990-95) > 178 g in 1 TUBE1 tube2021-01-290000-00-00NoNoCurrent
35000-990-99350000990991 TUBE in 1 CARTON (35000-990-99) / 53.8 g in 1 TUBE1 tube2020-10-010000-00-00NoNoCurrent