Home NDC 35000-683 Hello Peace Out Plaque
Product NDC 35000-683
11-digit product format 350000683
Labeler code 35000
Product ID 35000-683_1a456063-e89d-4697-8a54-54094a28696e
Type HUMAN OTC DRUG
Nonproprietary name CETYLPYRIDINIUM CHLORIDE
Dosage form MOUTHWASH
Route DENTAL
Labeler Colgate-Palmolive Company
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Marketing end 2027-12-30
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 15 mg/20mL
NDC exclude flag No
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persist for more than two weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Hello Peace Out Plaque
Brand name suffix peace out, plaque antigingivitis Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 15 mg/20mL
Harmonized Identifiers# Field, Values table Field Values Unii D9OM4SK49P Rxcui 1599135
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-683-10 Hello Peace Out Plaquepeace out, plaque antigingivitis 473 mL in 1 BOTTLE MOUTHWASH 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-683 HELLO PEACE OUT PLAQUE PEACE OUT, PLAQUE ANTIGINGIVITIS (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [COLGATE-PALMOLIVE COMPANY] 7 Current NDC, 1 package rows 20250418_a0fb33a6-621f-a972-2ff7-1bb899f27f3b.zip
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 35000-683-10 35000068310 473 mL in 1 BOTTLE (35000-683-10) 473 ml 2023-07-01 2027-12-30 No No Historical