Home NDC 0126-0034 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Product NDC 0126-0034
11-digit product format 001260034
Labeler code 0126
Product ID 0126-0034_0c0515c6-25cb-46b6-ada6-79f8aeb97a28
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form RINSE
Route DENTAL
Labeler Colgate Oral Pharmaceuticals, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-02-15
Substance SODIUM FLUORIDE
Active strength 2 mg/10mL
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 Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313029 Internal RxNorm lookup 1721964 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0126-0034-46 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 500 mL in 1 BOTTLE RINSE 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0126-0034 COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE (SODIUM FLUORIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20240113_9a976ac8-d966-4d94-93da-45652f2d2481.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 45 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 0126-0034-46 00126003446 500 mL in 1 BOTTLE (0126-0034-46) 500 ml 2011-02-15 0000-00-00 No No Current