Home NDC 35000-978 Colgate Optic White Advanced Sparkling White
Product NDC 35000-978
11-digit product format 350000978
Labeler code 35000
Product ID 35000-978_ab74961c-dfbd-4213-bb8f-f65cf6be852a
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 2019-10-14
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1 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 Optic White Advanced Sparkling White
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 35000-978-14 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4 35000-978-14 Colgate Optic White Advanced Sparkling White 41 g in 1 TUBE PASTE, DENTIFRICE 41 4 35000-978-16 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4 35000-978-16 Colgate Optic White Advanced Sparkling White 21.2 g in 1 TUBE PASTE, DENTIFRICE 21.2 4 35000-978-25 Colgate Optic White Advanced Sparkling White 70.8 g in 1 TUBE PASTE, DENTIFRICE 70.8 4 35000-978-25 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4 35000-978-32 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4 35000-978-32 Colgate Optic White Advanced Sparkling White 90 g in 1 TUBE PASTE, DENTIFRICE 90 4 35000-978-44 Colgate Optic White Advanced Sparkling White 127 g in 1 TUBE PASTE, DENTIFRICE 127 4 35000-978-44 Colgate Optic White Advanced Sparkling White 2 in 1 CARTON PASTE, DENTIFRICE 2 4 35000-978-71 Colgate Optic White Advanced Sparkling White 119 g in 1 TUBE PASTE, DENTIFRICE 119 4 35000-978-71 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4 35000-978-76 Colgate Optic White Advanced Sparkling White 90 g in 1 TUBE PASTE, DENTIFRICE 90 4 35000-978-76 Colgate Optic White Advanced Sparkling White 2 in 1 CARTON PASTE, DENTIFRICE 2 4 35000-978-86 Colgate Optic White Advanced Sparkling White 127 g in 1 TUBE PASTE, DENTIFRICE 127 4 35000-978-86 Colgate Optic White Advanced Sparkling White 1 in 1 CARTON PASTE, DENTIFRICE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-978 COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY] 3 Current NDC, Legacy NDC, 16 package rows 20241017_bc56603d-4190-48c1-b16e-3179a650cb39.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 30 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 35000-978-14 35000097814 1 TUBE in 1 CARTON (35000-978-14) / 41 g in 1 TUBE 1 tube 2019-10-14 0000-00-00 No No Current 35000-978-16 35000097816 1 TUBE in 1 CARTON (35000-978-16) / 21.2 g in 1 TUBE 1 tube 2019-10-14 0000-00-00 No No Current 35000-978-25 35000097825 1 TUBE in 1 CARTON (35000-978-25) / 70.8 g in 1 TUBE 1 tube 2026-01-01 No No Current 35000-978-32 35000097832 1 TUBE in 1 CARTON (35000-978-32) / 90 g in 1 TUBE 1 tube 2019-10-14 0000-00-00 No No Current 35000-978-44 35000097844 2 TUBE in 1 CARTON (35000-978-44) / 127 g in 1 TUBE 2 tube 2019-10-14 0000-00-00 No No Current 35000-978-71 35000097871 1 TUBE in 1 CARTON (35000-978-71) / 119 g in 1 TUBE 1 tube 2019-11-26 0000-00-00 No No Current 35000-978-76 35000097876 2 TUBE in 1 CARTON (35000-978-76) / 90 g in 1 TUBE 2 tube 2019-10-14 0000-00-00 No No Current 35000-978-86 35000097886 1 TUBE in 1 CARTON (35000-978-86) / 127 g in 1 TUBE 1 tube 2019-10-14 0000-00-00 No No Current