FDA.reportPublic FDA data

Colgate MaxFresh Charcoal

Product NDC
35000-990
11-digit product format
350000990
Labeler code
35000
Product ID
35000-990_447f0849-ffaf-47c0-94ff-d29f78a90509
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-99035000-990-34DDiscontinued by firm2026-10-15
excluded packagepackage35000-99035000-990-60DDiscontinued by firm2026-10-15
excluded packagepackage35000-99035000-990-95DDiscontinued by firm2026-10-15
excluded packagepackage35000-99035000-990-99DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
890c4c29-bba8-4775-a053-10c6292df930Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-13WarningsExact identifier
application number: M021
COLGATE STRAWBERRY BURSTSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-13WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRYSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.e36ceb7a-9a29-41d8-8d08-a859e515f1f52026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.08d7ed04-67a4-437a-82c5-496f9893c6c72026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.27278b02-c4fd-4092-a632-a14e442f5a952026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICESODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.59a6b9ac-c28b-4ec3-8231-f35054ce0eaf2026-08-10WarningsExact identifier
application number: M021
Toms Kids Watermelon WiggleSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.48eaafb6-99f4-5fd1-10fc-4ea35cbb2c622026-08-10WarningsExact identifier
application number: M021
AutoBrush kids bubblegumSODIUM FLUORIDELander Enterprises, LLC64b60e74-fceb-4de9-a966-73bf8dbd666c2026-08-10WarningsExact identifier
application number: M021
AutoBrush kids strawberrySODIUM FLUORIDELander Enterprises, LLC7e880d50-8aab-4d57-abc1-e900070f9a112026-08-10WarningsExact identifier
application number: M021
AutoBrush kids watermelonSODIUM FLUORIDELander Enterprises, LLC5cb5eb46-705c-4bb7-bef1-e93a598636fd2026-08-10WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
application number: M021
Willo Minty Mist Dye FreeSODIUM FLUORIDEWillo 32, Inc.3ee5b49e-ca9a-ece6-e063-6394a90a3d002026-08-10WarningsExact identifier
application number: M021
Willo Bubble TwistSODIUM FLUORIDEWillo 32 Inc36560d62-e901-1f93-e063-6394a90a28032026-08-10WarningsExact identifier
application number: M021
Willo Berry Splash Dye FreeSODIUM FLUORIDEWillo 32, Inc3ea91af9-2895-e530-e063-6394a90a39e52026-08-10WarningsExact identifier
application number: M021
Fluoride Mouth Rinse AnticavitySODIUM FLUORIDETarget Corporation3daf3cc3-585a-4bb2-9b56-7117d220ed382026-08-10Warnings, Adverse reactionsExact identifier
application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.d5e1396e-0253-4ec0-a9ff-b61bda70de352026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED COOL MILD MINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.de92408c-d401-47c3-94ee-fb6c080926512026-08-10WarningsExact identifier
application number: M021

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 tube2024-06-17NoNoCurrent
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