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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINTSODIUM FLUORIDETom's of Maine, Inc.b9e6e455-8444-4805-89f1-ee9142f98e362026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.7db8e49d-1073-4a81-a3a4-f3a19ebce9212026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINTSODIUM FLUORIDETom's of Maine, Inc.1fe50b49-bc62-4137-866c-e87bb878a96d2026-08-10WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact 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