FDA.reportPublic FDA data

Colgate

Product NDC
35000-903
11-digit product format
350000903
Labeler code
35000
Product ID
35000-903_14f9feea-6d53-476e-84c5-4a6cabd5c0ac
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
2011-08-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-90335000-903-60DDiscontinued by firm2026-10-12
excluded packagepackage35000-90335000-903-75DDiscontinued by firm2026-10-12
excluded packagepackage35000-90335000-903-78DDiscontinued by firm2026-10-12

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 2025-12-0535000-903-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-903-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-903-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-903-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-903-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-903-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-903-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-903-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-903-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-903-78cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-903-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-903-78cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-903-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-903-78302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-903-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-903-78ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-903-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-903-780efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-903-750efc9e666f02…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
Brand name suffix
Max Fresh Cool Mint
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
00652bb2-090c-4eaa-8fc2-e0be6913a724Available 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
35000-903-01ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-01ColgateMax Fresh Cool Mint28.3 g in 1 TUBEGEL, DENTIFRICE28.36
35000-903-58ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-58ColgateMax Fresh Cool Mint70 g in 1 TUBEGEL, DENTIFRICE706
35000-903-60ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-60ColgateMax Fresh Cool Mint170 g in 1 TUBEGEL, DENTIFRICE1706
35000-903-75ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-75ColgateMax Fresh Cool Mint79 g in 1 TUBEGEL, DENTIFRICE796
35000-903-78ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-78ColgateMax Fresh Cool Mint221 g in 1 TUBEGEL, DENTIFRICE2216
35000-903-95ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-95ColgateMax Fresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE1786
35000-903-99ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-99ColgateMax Fresh Cool Mint53 g in 1 TUBEGEL, DENTIFRICE536

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-903COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Current NDC, Legacy NDC, 14 package rows20241127_00652bb2-090c-4eaa-8fc2-e0be6913a724.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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-903-01350000903011 TUBE in 1 CARTON (35000-903-01) / 28.3 g in 1 TUBE1 tube2020-05-180000-00-00NoNoCurrent
35000-903-58350000903581 TUBE in 1 CARTON (35000-903-58) / 70 g in 1 TUBE1 tube2020-06-090000-00-00NoNoCurrent
35000-903-60350000903601 TUBE in 1 CARTON (35000-903-60) > 170 g in 1 TUBE1 tube2011-08-010000-00-00NoNoCurrent
35000-903-63350000903631 TUBE in 1 CARTON (35000-903-63) > 178 g in 1 TUBE1 tube2022-06-070000-00-00NoNoCurrent
35000-903-75350000903751 TUBE in 1 CARTON (35000-903-75) > 79 g in 1 TUBE1 tube2011-08-010000-00-00NoNoCurrent
35000-903-78350000903781 TUBE in 1 CARTON (35000-903-78) > 221 g in 1 TUBE1 tube2011-08-010000-00-00NoNoCurrent
35000-903-95350000903951 TUBE in 1 CARTON (35000-903-95) / 178 g in 1 TUBE1 tube2024-06-08NoNoCurrent
35000-903-99350000903991 TUBE in 1 CARTON (35000-903-99) / 53 g in 1 TUBE1 tube2020-05-210000-00-00NoNoCurrent