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 firm2026-10-15
excluded packagepackage35000-89935000-899-58DDiscontinued by firm2026-10-15
excluded packagepackage35000-89935000-899-60DDiscontinued by firm2026-10-15

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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
application number: M021
Burts Bees Complete Multi-CareSODIUM FLUORIDEProcter & Gamble Manufacturing Company12615266-06e8-b891-e063-6394a90ad75d2026-02-02WarningsExact identifier
application number: M021
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Cars Chow CherrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d66ad5-cdae-52f4-e063-6294a90a8ee92026-02-01WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
application number: M021
ACT Kids Berry BlastSODIUM FLUORIDEChattem, Inc.4f81ea98-5c74-4473-9764-3f11d627cdf12026-02-01WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
application number: M021
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
application number: M021
Supersmile Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc24fee793-57ed-87e9-e063-6394a90ab4ce2026-01-28WarningsExact identifier
application number: M021
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
application number: M021
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
application number: M021
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact 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