FDA.reportPublic FDA data

Colgate MaxFresh

Product NDC
35000-430
11-digit product format
350000430
Labeler code
35000
Product ID
35000-430_5e5f334c-1a38-43c7-ba91-e6a55090e83e
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
2024-05-28
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Brand name suffix
Clean 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
7cb85fc4-573b-45d7-a430-f2fd17320c43Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-430-58ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13
35000-430-58ColgateMax Fresh Clean Mint70 g in 1 TUBEGEL, DENTIFRICE703
35000-430-95ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13
35000-430-95ColgateMax Fresh Clean Mint179 g in 1 TUBEGEL, DENTIFRICE1793
35000-430-99ColgateMax Fresh Clean Mint53.8 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE53.83
35000-430-99ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-430COLGATE MAX FRESH CLEAN MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Current NDC, 6 package rows20240619_7cb85fc4-573b-45d7-a430-f2fd17320c43.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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-430-58350000430581 TUBE in 1 CARTON (35000-430-58) / 70 g in 1 TUBE1 tube2024-05-28NoNoCurrent
35000-430-95350000430951 TUBE in 1 CARTON (35000-430-95) / 179 g in 1 TUBE1 tube2024-06-17NoNoCurrent
35000-430-99350000430991 TUBE in 1 CARTON (35000-430-99) / 53.8 g in 1 TUBE1 tube2025-08-01NoNoCurrent