Home NDC 35000-913 COLGATE Great Regular Flavor
Product NDC 35000-913
11-digit product format 350000913
Labeler code 35000
Product ID 35000-913_5c864eeb-a3fa-4e6a-b624-29ed3cd6d2da
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-11-05
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 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 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Great Regular Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 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 35000-913-01 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-01 COLGATE Great Regular Flavor 28 g in 1 TUBE PASTE, DENTIFRICE 28 3 35000-913-04 COLGATE Great Regular Flavor 4.25 g in 1 POUCH PASTE, DENTIFRICE 4.25 3 35000-913-20 COLGATE Great Regular Flavor 24 g in 1 TUBE PASTE, DENTIFRICE 24 3 35000-913-30 COLGATE Great Regular Flavor 170 g in 1 TUBE PASTE, DENTIFRICE 170 3 35000-913-30 COLGATE Great Regular Flavor 3 in 1 CARTON PASTE, DENTIFRICE 3 3 35000-913-33 COLGATE Great Regular Flavor 36.8 g in 1 TUBE PASTE, DENTIFRICE 36.8 3 35000-913-33 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-46 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-46 COLGATE Great Regular Flavor 130 g in 1 TUBE PASTE, DENTIFRICE 130 3 35000-913-48 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-48 COLGATE Great Regular Flavor 226 g in 1 TUBE PASTE, DENTIFRICE 226 3 35000-913-58 COLGATE Great Regular Flavor 70 g in 1 TUBE PASTE, DENTIFRICE 70 3 35000-913-58 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-60 COLGATE Great Regular Flavor 170 g in 1 TUBE PASTE, DENTIFRICE 170 3 35000-913-64 COLGATE Great Regular Flavor 181 g in 1 TUBE PASTE, DENTIFRICE 181 3 35000-913-64 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-69 COLGATE Great Regular Flavor 113 g in 1 TUBE PASTE, DENTIFRICE 113 3 35000-913-69 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-79 COLGATE Great Regular Flavor 79 g in 1 TUBE PASTE, DENTIFRICE 79 3 35000-913-79 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-82 COLGATE Great Regular Flavor 232 g in 1 TUBE PASTE, DENTIFRICE 232 3 35000-913-82 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-92 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 3 35000-913-92 COLGATE Great Regular Flavor 141 g in 1 TUBE PASTE, DENTIFRICE 141 3 35000-913-93 COLGATE Great Regular Flavor 99 g in 1 TUBE PASTE, DENTIFRICE 99 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-913 COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] 3 Current NDC, Legacy NDC, 26 package rows 20241127_730f40f6-6ac6-49bd-888b-c0b5818a03c8.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 10 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frida Fluoride Sweet Mint SODIUM FLUORIDE Fridababy, LLC 4f8b5a39-5d79-72cd-e063-6394a90a475c 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Bubble Mint SODIUM FLUORIDE Fridababy, LLC 4f8b9af3-e4b3-b5e0-e063-6394a90a1068 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry Toothbrush Set SODIUM FLUORIDE Fridababy, LLC 4f8ba14f-60ea-c2a8-e063-6394a90a7702 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry SODIUM FLUORIDE Fridababy, LLC 4f814a62-8f91-8ea6-e063-6294a90a69eb 2026-05-06 Warnings Exact identifier application number: M021 Gum Health Detoxify STANNOUS FLUORIDE Meijer, Inc 41d70733-a223-40fb-e063-6294a90a1397 2026-05-06 Warnings Exact identifier application number: M021 Colgate Kids Unicorn Alcohol Free SODIUM FLUORIDE Colgate-Palmolive Company 133acaff-7205-80d7-e91d-3eb37087cae4 2026-05-05 Warnings Exact identifier application number: M021 Crest 3D White Stain Eraser SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. fdefffbd-9c05-fa30-e053-6394a90a34bc 2026-05-05 Warnings Exact identifier application number: M021 Frida Fluoride Watermelon SODIUM FLUORIDE Fridababy, LLC 4f8b49dc-e9e4-c341-e063-6294a90adb5a 2026-05-05 Warnings Exact identifier application number: M021 White Glo Extreme White Whitening SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 4a2e0a8d-420e-4c07-aa43-386d05dab472 2026-04-30 Warnings Exact identifier application number: M021 Equate Pro-Advanced TP Equate Pro-Advanced TP STANNOUS FLUORIDE Walmart Inc. 1e6561fb-4e3b-40ba-e063-6294a90a2690 2026-04-29 Warnings Exact identifier application number: M021 Crest Cavity Protection Regular SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 852889b4-59ba-4592-b4fc-c0127a1ad075 2026-04-28 Warnings Exact identifier application number: M021 Crest Complete Multi-Benefit Whitening plus Scope SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 0206710a-707f-4aa9-96b9-86240c1275dc 2026-04-28 Warnings Exact identifier application number: M021 Alcohol Free Refreshing Mint SODIUM FLUORIDE H E B cedf7c08-7412-4733-9b67-225b331cec8c 2026-04-27 Warnings, Adverse reactions Exact identifier application number: M021 anzoon ANTIBACTERIAL MOUTH WASH CETYLPYRIDINIUM CHLORIDE Shandong AZC Biotechnology Co.,Ltd. 507c6896-2806-790c-e063-6394a90ac5ce 2026-04-27 Warnings Exact identifier application number: M021 DELTA COMFORT PLUS AMENITY SODIUM MONOFLUOROPHOSPHATE Buzz Products Inc. 26434794-ae02-0f58-e063-6294a90ad85e 2026-04-24 Warnings Exact identifier application number: M021 A and H Plus Therabreath Breath Freshners SODIUM FLUORIDE Church & Dwight Co., Inc. 18d6073e-b1ee-47d2-9758-2cf04f3cf3ca 2026-04-23 Warnings Exact identifier application number: M021 Fluoride SODIUM FLUORIDE McKesson 5025e58e-e59c-07b6-e063-6394a90ac1e8 2026-04-23 Warnings Exact identifier application number: M021 PRO-SYS SENSITIVITY - MINT (OTC) Benco Dental 4e46847e-8c1d-c988-e063-6394a90a8e50 2026-04-22 Warnings Exact identifier application number: M021 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B 87327a36-a314-4daa-83b6-b4bd3e26bba2 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021 Anticavity SODIUM FLUORIDE H E B 8df324a7-9204-40f3-8ddb-1656286d7d4e 2026-04-22 Warnings, Adverse reactions 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 Marketing end Sample Exclude flag Status 35000-913-01 35000091301 1 TUBE in 1 CARTON (35000-913-01) / 28 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-04 35000091304 4.25 g in 1 POUCH (35000-913-04) 4.25 g 2005-11-05 0000-00-00 No No Current 35000-913-20 35000091320 24 g in 1 TUBE (35000-913-20) 24 g 2005-11-05 0000-00-00 No No Current 35000-913-30 35000091330 3 TUBE in 1 CARTON (35000-913-30) / 170 g in 1 TUBE 3 tube 2005-11-05 No No Current 35000-913-33 35000091333 1 TUBE in 1 CARTON (35000-913-33) > 36.8 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-34 35000091334 2 TUBE in 1 CARTON (35000-913-34) / 170 g in 1 TUBE 2 tube 2024-01-01 No No Current 35000-913-46 35000091346 1 TUBE in 1 CARTON (35000-913-46) > 130 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-48 35000091348 1 TUBE in 1 CARTON (35000-913-48) / 226 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-58 35000091358 1 TUBE in 1 CARTON (35000-913-58) / 70 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-60 35000091360 170 g in 1 TUBE (35000-913-60) 170 g 2005-11-05 0000-00-00 No No Current 35000-913-62 35000091362 1 TUBE in 1 CARTON (35000-913-62) / 170 g in 1 TUBE 1 tube 2026-01-01 No No Current 35000-913-64 35000091364 1 TUBE in 1 CARTON (35000-913-64) > 181 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-69 35000091369 1 TUBE in 1 CARTON (35000-913-69) / 113 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-79 35000091379 1 TUBE in 1 CARTON (35000-913-79) > 79 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-82 35000091382 1 TUBE in 1 CARTON (35000-913-82) > 232 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-92 35000091392 1 TUBE in 1 CARTON (35000-913-92) / 141 g in 1 TUBE 1 tube 2005-11-05 0000-00-00 No No Current 35000-913-93 35000091393 99 g in 1 TUBE (35000-913-93) 99 g 2005-11-05 0000-00-00 No No Current