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 43 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Listerine Total Care Zero Alcohol Anticavity Fresh Mint SODIUM FLUORIDE Kenvue Brands LLC 4b594a6e-db1d-443b-bfa7-23ee15749f47 2024-12-19 Warnings Exact identifier application number: M021 NewYork-Presbyterian Amenity SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 4b307471-445d-4c51-a499-d074a8172f20 2024-12-17 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive (Thailand) Limited - Branch 5bc0b430-6f68-4e52-a1da-de19136eaeac 2024-12-09 Warnings Exact identifier application number: M021 CURODONT REPAIR FLUORIDE PLUS SODIUM FLUORIDE CREDENTIS AG 03ec09f9-4281-9ccb-e063-6294a90aadd8 2024-12-01 Warnings Exact identifier application number: M021 CURODONT PROTECT STANNOUS FLUORIDE CREDENTIS AG 03ec591c-68c3-a380-e063-6394a90a131a 2024-12-01 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Bubble Gum Blowout SODIUM FLUORIDE Chattem, Inc. 61f3a3e6-645b-4368-b1d5-7de1fc14542e 2024-12-01 Warnings Exact identifier application number: M021 SparkleFresh Flouride Toothpaste SODIUM MONOFLUOROPHOSPHATE Medline Industries, LP 1565528b-89f2-4c97-b294-15b6ebd3f80e 2024-11-26 Warnings Exact identifier application number: M021 Rembrandt Intense Stain SODIUM FLUORIDE Ranir LLC 55dcd063-5661-35aa-e054-00144ff8d46c 2024-11-26 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC 9f98913f-6754-4e1c-98cf-b89fe87750f8 2024-11-25 Warnings Exact identifier application number: M021 Colgate Total SF Clean Mint STANNOUS FLUORIDE Colgate-Palmolive Company 88f87f7a-5b2d-47c9-8830-6b88b4ddbb59 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 0c85d273-3b98-43ea-81ba-c90f70ab72f8 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 2a882210-49e6-4b9c-a2c6-eaa37b6514c3 2024-11-25 Warnings Exact identifier application number: M021 Pepsodent Complete Care Original SODIUM FLUORIDE Church & Dwight Co., Inc. 3c6931cb-0ec9-41bb-b410-c355573aab57 2024-11-21 Warnings Exact identifier application number: M021 Firefly Strawberry Natural Fluoride SODIUM FLUORIDE Ranir LLC 8ee37955-fe1a-4964-ac29-d1d7dfb694cc 2024-11-21 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC abdc7f79-5f87-4307-8ddd-e6281ac67a04 2024-11-20 Warnings Exact identifier application number: M021 AIM Bubble Berry SODIUM FLUORIDE Church & Dwight Co., Inc. c83ccdea-d75f-4084-853e-ed4bab9a12d4 2024-11-20 Warnings Exact identifier application number: M021 AIM TARTAR CONTROL Plus Mouthwash and Whitening SODIUM FLUORIDE Church & Dwight Co., Inc. 1d0fc71c-d28e-4afa-e054-00144ff8d46c 2024-11-20 Warnings Exact identifier application number: M021 Advance White Tartar Control Breath Freshening SODIUM FLUORIDE Church & Dwight Co., Inc. aa8be8f5-ba46-4b1b-afaa-58fddf8f8780 2024-11-20 Warnings Exact identifier application number: M021 Enamel Defense SODIUM FLUORIDE Church & Dwight Co., Inc. 9e8f1ce9-b161-50db-e053-2995a90ad32b 2024-11-20 Warnings Exact identifier application number: M021 Rembrandt Deeply White Plus Peroxide SODIUM MONOFLUOROPHOSPHATE Ranir LLC bf7da007-ab9d-4631-bc28-6ca245fd6265 2024-11-20 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 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