FDA.reportPublic FDA data

Colgate Max Fresh

Product NDC
35000-899
11-digit product format
350000899
Labeler code
35000
Product ID
35000-899_61aad525-7efb-4404-bc6c-ab625e045332
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
2021-10-16
Substance
SODIUM FLUORIDE
Active strength
2.4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-89935000-899-34DDiscontinued by firm2026-10-05
excluded packagepackage35000-89935000-899-58DDiscontinued by firm2026-10-05
excluded packagepackage35000-89935000-899-60DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0535000-899-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-899-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-899-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-899-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-899-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-899-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-899-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-899-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-899-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-899-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-899-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-899-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-899-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-899-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-899-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-899-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-899-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-899-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-899-340efc9e666f02…f202fb6c5f17…

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 Max Fresh
Brand name suffix
Advanced Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 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
01c07c25-2748-4d90-9505-094e2c977c9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
35000-899-34Colgate Max FreshAdvanced Whitening2 in 1 CARTONGEL, DENTIFRICE27
35000-899-34Colgate Max FreshAdvanced Whitening170 g in 1 TUBEGEL, DENTIFRICE1707
35000-899-58Colgate Max FreshAdvanced Whitening70.87 g in 1 TUBEGEL, DENTIFRICE70.877
35000-899-58Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-60Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-60Colgate Max FreshAdvanced Whitening170 g in 1 TUBEGEL, DENTIFRICE1707
35000-899-78Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-78Colgate Max FreshAdvanced Whitening70.8 g in 1 TUBEGEL, DENTIFRICE70.87
35000-899-95Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-95Colgate Max FreshAdvanced Whitening178 g in 1 TUBEGEL, DENTIFRICE1787

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-899COLGATE MAX FRESH ADVANCED WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]6Current NDC, Legacy NDC, 10 package rows20250110_01c07c25-2748-4d90-9505-094e2c977c9c.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 % ToothpastePSN01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-899-34350000899342 TUBE in 1 CARTON (35000-899-34) > 170 g in 1 TUBE2 tube2021-10-160000-00-00NoNoCurrent
35000-899-583500008995870.87 g in 1 TUBE70.87 gHistorical
35000-899-60350000899601 TUBE in 1 CARTON (35000-899-60) > 170 g in 1 TUBE1 tube2021-10-160000-00-00NoNoCurrent
35000-899-78350000899781 TUBE in 1 CARTON (35000-899-78) / 70.8 g in 1 TUBE1 tube2024-01-01NoNoCurrent
35000-899-95350000899951 TUBE in 1 CARTON (35000-899-95) / 178 g in 1 TUBE1 tube2021-10-162027-09-01NoNoCurrent