Home NDC 0135-0737 parodontax
Product NDC 0135-0737
11-digit product format 001350737
Labeler code 0135
Product ID 0135-0737_8d02125c-336e-4b68-a49d-1cffd670ed6b
Type HUMAN OTC DRUG
Nonproprietary name stannous fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-02
Substance STANNOUS FLUORIDE
Active strength 1.1 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 Active Gum Repair Breath Freshener
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS 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 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0737-01 parodontaxActive Gum Repair Breath Freshener 96.4 g in 1 TUBE PASTE 96.4 6 0135-0737-01 parodontaxActive Gum Repair Breath Freshener 1 in 1 CARTON PASTE 1 6 0135-0737-02 parodontaxActive Gum Repair Breath Freshener 23 g in 1 TUBE PASTE 23 6 0135-0737-02 parodontaxActive Gum Repair Breath Freshener 1 in 1 CARTON PASTE 1 6 0135-0737-03 parodontaxActive Gum Repair Breath Freshener 65 g in 1 TUBE PASTE 65 6 0135-0737-03 parodontaxActive Gum Repair Breath Freshener 1 in 1 CARTON PASTE 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0737 PARODONTAX ACTIVE GUM REPAIR BREATH FRESHENER (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 5 Current NDC, 6 package rows 20250215_addcb1e2-24b9-4367-adf3-6806e2439a80.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 9 of 40 · 786 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 0135-0737-01 00135073701 1 TUBE in 1 CARTON (0135-0737-01) / 96.4 g in 1 TUBE 1 tube 2024-01-02 No No Current 0135-0737-02 00135073702 1 TUBE in 1 CARTON (0135-0737-02) / 23 g in 1 TUBE 1 tube 2024-01-02 No No Current 0135-0737-03 00135073703 1 TUBE in 1 CARTON (0135-0737-03) / 65 g in 1 TUBE 1 tube 2025-01-02 No No Current