Home NDC 35000-211 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
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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35000-211 35000-211-54 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…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 Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-211-30 Colgate MaxFresh Cool Mint 3 in 1 CELLO PACK GEL, DENTIFRICE 3 4 35000-211-30 Colgate MaxFresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 4 35000-211-54 Colgate MaxFresh Cool Mint 198 g in 1 TUBE GEL, DENTIFRICE 198 4 35000-211-54 Colgate MaxFresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 4 35000-211-55 Colgate MaxFresh Cool Mint 170 g in 1 TUBE GEL, DENTIFRICE 170 4 35000-211-55 Colgate MaxFresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 4 35000-211-73 Colgate MaxFresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 4 35000-211-73 Colgate MaxFresh Cool Mint 206 g in 1 TUBE GEL, DENTIFRICE 206 4 35000-211-95 Colgate MaxFresh Cool Mint 178 g in 1 TUBE GEL, DENTIFRICE 178 4 35000-211-95 Colgate MaxFresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-211 COLGATE MAXFRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE PALMOLIVE COMPANY] 3 Current NDC, 10 package rows 20250119_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 34 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hello Whipped Mellow Mint Dream Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 7a72b687-475d-437a-9734-a29637e5516a 2025-11-11 Warnings Exact identifier application number: M021 Spry Dentifrice TOOTHPASTE Xlear Inc. 43567bbc-b07e-b605-e063-6294a90aad78 2025-11-11 Warnings Exact identifier application number: M021 Hello Naturally Whitening SODIUM MONOFLUOROPHOSPHATE COLGATE PALMOLIVE COMPANY 5ad241e1-6bfc-7863-6a7a-100753651f0a 2025-11-11 Warnings Exact identifier application number: M021 Hello Whipped Peppermint Stick Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company d6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f813 2025-11-11 Warnings Exact identifier application number: M021 Super Mint MINT TOOTHPASTE SuperMouth, LLC. d23e89f5-7b65-4ed9-803a-38233f30d8f2 2025-11-07 Warnings Exact identifier application number: M021 Dentisse SODIUM FLUORIDE Dentisse, Inc. 326b290a-9bd2-468e-e054-00144ff8d46c 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 51f1d84c-809a-4c96-a117-7a8d8aa1e6b4 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. c44686f8-93ee-4a8f-8481-3439d123f6d2 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 16ebcb37-5703-4e10-b965-570e18434b52 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker GREAT WHITE SHARK SODIUM FLUORIDE YOUNG PS ACQUISITION, LLC ca5b91aa-f69c-4553-a2b6-acf0ca1d920e 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65fa41e-ce2e-53e4-e053-2995a90a24d2 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65c62d9-e8a6-3101-e053-2995a90a1494 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75 2025-11-04 Warnings Exact identifier application number: M021 Strawberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426c2aca-ca2b-5e34-e063-6294a90ae37c 2025-11-02 Warnings Exact identifier application number: M021 Watermelon Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426e40cb-e30d-0db1-e063-6294a90a762b 2025-10-31 Warnings Exact identifier application number: M021 Classic Mint Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425a9b71-5a7f-83e6-e063-6394a90ab703 2025-10-30 Warnings Exact identifier application number: M021 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425b1a2e-7576-13a7-e063-6394a90aa865 2025-10-30 Warnings Exact identifier application number: M021 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426b8efa-e691-a67d-e063-6394a90abf8d 2025-10-30 Warnings Exact identifier application number: M021 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 42583b32-525f-925d-e063-6294a90af76f 2025-10-29 Warnings Exact identifier application number: M021 PERIOE KAKAO KIDS Strawberry SODIUM FLUORIDE LG HOUSEHOLD & HEALTH CARE LTD. 4239f8c2-a5f5-3fa6-e063-6294a90acb47 2025-10-28 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35000-211-30 35000021130 3 CARTON in 1 CELLO PACK (35000-211-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE 3 carton 2025-02-03 No No Current 35000-211-54 35000021154 198 g in 1 TUBE 198 g Historical 35000-211-55 35000021155 2 TUBE in 1 CARTON (35000-211-55) / 178 g in 1 TUBE 2 tube 2025-11-01 No No Current 35000-211-73 35000021173 1 TUBE in 1 CARTON (35000-211-73) / 206 g in 1 TUBE 1 tube 2025-02-03 No No Current 35000-211-95 35000021195 1 TUBE in 1 CARTON (35000-211-95) / 178 g in 1 TUBE 1 tube 2025-02-03 No No Current