Home NDC 0135-0655 Parodontax
Product NDC 0135-0655
11-digit product format 001350655
Labeler code 0135
Product ID 0135-0655_42f314be-90cb-0204-e063-6394a90a22c3
Type HUMAN OTC DRUG
Nonproprietary name stannous fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-15
Substance STANNOUS FLUORIDE
Active strength 1.5 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Parodontax
Brand name suffix Gum Strengthen and Protect
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 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 0135-0655-01 ParodontaxGum Strengthen and Protect 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 2 0135-0655-01 ParodontaxGum Strengthen and Protect 1 in 1 CARTON PASTE, DENTIFRICE 1 2
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 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0135-0655-01 00135065501 1 TUBE in 1 CARTON (0135-0655-01) / 96.4 g in 1 TUBE 1 tube 2025-12-15 No No Current