Home NDC 35000-127 Colgate MaxFresh Knockout
Product NDC 35000-127
11-digit product format 350000127
Labeler code 35000
Product ID 35000-127_aa4c35c1-54b0-42a0-abec-a41932c0821c
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler COLGATE PALMOLIVE COMPANY
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-24
Marketing end 2026-12-30
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
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 · 21 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 MaxFresh Knockout Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 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 35000-127-30 Colgate MaxFresh Knockout 1 in 1 CARTON PASTE, DENTIFRICE 1 14 35000-127-30 Colgate MaxFresh Knockout 3 in 1 CELLO PACK PASTE, DENTIFRICE 3 14 35000-127-60 Colgate MaxFresh Knockout 170 g in 1 TUBE PASTE, DENTIFRICE 170 14 35000-127-60 Colgate MaxFresh Knockout 1 in 1 CARTON PASTE, DENTIFRICE 1 14 35000-127-74 Colgate MaxFresh Knockout 1 in 1 CARTON PASTE, DENTIFRICE 1 14 35000-127-74 Colgate MaxFresh Knockout 182 g in 1 TUBE PASTE, DENTIFRICE 182 14 35000-127-95 Colgate MaxFresh Knockout 178 g in 1 TUBE PASTE, DENTIFRICE 178 14 35000-127-95 Colgate MaxFresh Knockout 1 in 1 CARTON PASTE, DENTIFRICE 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-127 COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY] 13 Current NDC, Legacy NDC, 8 package rows 20241115_b6ca4ec7-5087-4693-82b7-199b44d7f931.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 5 of 50 · 995 matching rows.
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 35000-127-30 35000012730 3 CARTON in 1 CELLO PACK (35000-127-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE 3 carton 2023-07-24 2026-12-30 No No Historical 35000-127-60 35000012760 1 TUBE in 1 CARTON (35000-127-60) > 170 g in 1 TUBE 1 tube 2019-10-24 0000-00-00 No No Current 35000-127-74 35000012774 1 TUBE in 1 CARTON (35000-127-74) > 182 g in 1 TUBE 1 tube 2020-06-23 2022-12-31 No No Current 35000-127-95 35000012795 1 TUBE in 1 CARTON (35000-127-95) / 178 g in 1 TUBE 1 tube 2021-12-01 2026-12-30 No No Current