FDA.reportPublic FDA data

Colgate MaxFresh Cool Mint

Product NDC
35000-211
11-digit product format
350000211
Labeler code
35000
Product ID
35000-211_85b700ad-7cad-4a72-86b5-482e15b895fb
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
2025-01-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-21135000-211-54DDiscontinued 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35000-21135000-211-54DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Cool Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-211-30Colgate MaxFresh Cool Mint3 in 1 CELLO PACKGEL, DENTIFRICE34
35000-211-30Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-54Colgate MaxFresh Cool Mint198 g in 1 TUBEGEL, DENTIFRICE1984
35000-211-54Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-55Colgate MaxFresh Cool Mint170 g in 1 TUBEGEL, DENTIFRICE1704
35000-211-55Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-73Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-73Colgate MaxFresh Cool Mint206 g in 1 TUBEGEL, DENTIFRICE2064
35000-211-95Colgate MaxFresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE1784
35000-211-95Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-211COLGATE MAXFRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE PALMOLIVE COMPANY]3Current NDC, 10 package rows20250119_e3dd6d27-6607-4b0c-83e1-49d94be2e580.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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d4f96f-e61f-e6e6-e063-6294a90ab0a02026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Toy Story Wild West WatermelonSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d69901-0b07-b07d-e063-6394a90a3c342026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Frozen Blizzard BerrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6c1c9-cd21-cac6-e063-6294a90a81d62026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Princesses Grand GrapeSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6f926-da4e-26df-e063-6294a90a1c0c2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker PunchSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d70b88-d57c-37cd-e063-6294a90a4a592026-02-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERite Aid Corporation54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe2026-02-02Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-211-30350000211303 CARTON in 1 CELLO PACK (35000-211-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2025-02-03NoNoCurrent
35000-211-5435000021154198 g in 1 TUBE198 gHistorical
35000-211-55350000211552 TUBE in 1 CARTON (35000-211-55) / 178 g in 1 TUBE2 tube2025-11-01NoNoCurrent
35000-211-73350000211731 TUBE in 1 CARTON (35000-211-73) / 206 g in 1 TUBE1 tube2025-02-03NoNoCurrent
35000-211-95350000211951 TUBE in 1 CARTON (35000-211-95) / 178 g in 1 TUBE1 tube2025-02-03NoNoCurrent