Home NDC 0135-0638 parodontax
Product NDC 0135-0638
11-digit product format 001350638
Labeler code 0135
Product ID 0135-0638_7483472a-9e10-436c-aa9f-abe78b3f2d75
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 2022-01-03
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 Whitening
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0638-03 parodontaxActive Gum Repair Whitening 1 in 1 CARTON PASTE 1 5 0135-0638-03 parodontaxActive Gum Repair Whitening 65.2 g in 1 TUBE PASTE 65.2 5 0135-0638-04 parodontaxActive Gum Repair Whitening 1 in 1 CARTON PASTE 1 5 0135-0638-04 parodontaxActive Gum Repair Whitening 96.4 g in 1 TUBE PASTE 96.4 5 0135-0638-06 parodontaxActive Gum Repair Whitening 96.4 g in 1 TUBE PASTE 96.4 5 0135-0638-06 parodontaxActive Gum Repair Whitening 2 in 1 CARTON PASTE 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0638 PARODONTAX ACTIVE GUM REPAIR WHITENING (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 6 package rows 20250424_817e804c-e55e-4d77-9ab9-ff54ae794725.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 27 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 Marketing end Sample Exclude flag Status 0135-0638-03 00135063803 1 TUBE in 1 CARTON (0135-0638-03) / 65.2 g in 1 TUBE 1 tube 2022-01-03 0000-00-00 No No Current 0135-0638-04 00135063804 1 TUBE in 1 CARTON (0135-0638-04) / 96.4 g in 1 TUBE 1 tube 2022-01-03 0000-00-00 No No Current 0135-0638-06 00135063806 2 TUBE in 1 CARTON (0135-0638-06) / 96.4 g in 1 TUBE 2 tube 2025-04-01 No No Current