Home NDC 35000-789 COLGATE MAX FRESH COCONUT PINEAPPLE
Product NDC 35000-789
11-digit product format 350000789
Labeler code 35000
Product ID 35000-789_348b87b0-bdc4-4c76-8ff6-9b1a65e32260
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 2025-11-24
Substance SODIUM FLUORIDE
Active strength 2.4 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 MAX FRESH COCONUT PINEAPPLE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-789-86 COLGATE MAX FRESH COCONUT PINEAPPLE 127 g in 1 TUBE GEL, DENTIFRICE 127 5 35000-789-86 COLGATE MAX FRESH COCONUT PINEAPPLE 1 in 1 CARTON GEL, DENTIFRICE 1 5 35000-789-99 COLGATE MAX FRESH COCONUT PINEAPPLE 53.8 g in 1 TUBE GEL, DENTIFRICE 53.8 5 35000-789-99 COLGATE MAX FRESH COCONUT PINEAPPLE 1 in 1 CARTON GEL, DENTIFRICE 1 5
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 35 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Target Kids Watermelon Mint SODIUM FLUORIDE Target 35bc2e4d-f1c7-438e-e063-6394a90aead0 2025-10-17 Warnings Exact identifier application number: M021 MediChoice Fluoride SODIUM MONOFLUOROPHOSPHATE O&M HALYARD, INC. a87956fa-8975-4a44-9e9a-4b2191e401fe 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b6f893d-74ac-421e-a78b-f495ac425af0 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. a3e989f8-e6a2-4e13-8faa-77e95895166d 2025-10-09 Warnings Exact identifier application number: M021 TARGET UP AND UP ANTICAVITY SODIUM FLUORIDE 0.05% TARGET CORPORATION 2992efce-1c66-df40-e063-6294a90ab3c0 2025-10-08 Warnings Exact identifier application number: M021 MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE O&M HALYARD, INC. c6ba9b51-b958-4836-adc8-871529a43fc6 2025-10-08 Warnings Exact identifier application number: M021 Tidalove SPICY CINNAMON TOOTHPASTE TABLETS Paranmare LLC 4092fcbf-27f7-b067-e063-6394a90a41c6 2025-10-07 Warnings Exact identifier application number: M021 Tidalove COOL MINT TOOTHPASTE TABLETS Paranmare LLC 4093060c-23a5-c77a-e063-6394a90a9304 2025-10-07 Warnings Exact identifier application number: M021 Tidalove YUZU MINT TOOTHPASTE TABLETS Paranmare LLC 40946943-21cf-b114-e063-6394a90aed3f 2025-10-07 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC fdb16e59-5be1-4bd0-a940-d542d67fb2df 2025-10-02 Warnings Exact identifier application number: M021 Intensive Enamel Repair Whitening TP INTENSIVE ENAMEL REPAIR WHITENING TP Topco Associates LLC 3012a8da-7595-2f7c-e063-6294a90ae120 2025-09-30 Warnings Exact identifier application number: M021 Made by Dentists For Kids Eyeball Juice (Watermelon) SODIUM FLUORIDE MADE BY DENTISTS INC b2ad2b19-6fdf-454d-9b1d-49b1c81016fd 2025-09-30 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. a38363e6-7105-4663-95a0-09ecb2948f83 2025-09-30 Warnings Exact identifier application number: M021 UNPA CHA CHA TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fae966e-0246-b9f2-e063-6394a90a494c 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Tooth SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fb01bea-7205-49ba-e063-6294a90a3841 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Sensitive Care Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 3fb153f1-ba6e-7251-e063-6294a90abe62 2025-09-26 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE DONG IL PHARMS CO.,LTD 3fb1a2ee-381e-a9e8-e063-6394a90a864b 2025-09-26 Warnings Exact identifier application number: M021 unpa Cha Cha Toothpaste SODIUM MONOFLUOROPHOSPHATE Lycl Inc. 230b3cf2-053a-4e8b-8d50-05bbc877faa8 2025-09-25 Warnings Exact identifier application number: M021 TheraBreath Anticavity SODIUM FLUORIDE Church & Dwight Co., Inc. 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da 2025-09-19 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1 2025-09-18 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 35000-789-86 35000078986 1 TUBE in 1 CARTON (35000-789-86) / 127 g in 1 TUBE 1 tube 2025-11-24 No No Current 35000-789-99 35000078999 1 TUBE in 1 CARTON (35000-789-99) / 53.8 g in 1 TUBE 1 tube 2026-04-01 No No Current