Home NDC 0135-0637 parodontax
Product NDC 0135-0637
11-digit product format 001350637
Labeler code 0135
Product ID 0135-0637_1286328e-795c-46dc-b43d-1257607f3f2f
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 2021-01-04
Substance STANNOUS FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 0135-0637 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0135-0637 0135-0637-02 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0135-0637 0135-0637-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0637-01 parodontaxActive Gum Repair 1 in 1 CARTON PASTE 1 7 0135-0637-01 parodontaxActive Gum Repair 96.4 g in 1 TUBE PASTE 96.4 7 0135-0637-02 parodontaxActive Gum Repair 1 in 1 CARTON PASTE 1 7 0135-0637-02 parodontaxActive Gum Repair 22.7 g in 1 TUBE PASTE 22.7 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0637 PARODONTAX ACTIVE GUM REPAIR (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250410_b51ccdd9-c0af-4caa-ad97-ad1d1423b76b.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 14 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 0135-0637-01 00135063701 1 TUBE in 1 CARTON (0135-0637-01) / 96.4 g in 1 TUBE 1 tube 2021-01-04 0000-00-00 No No Current 0135-0637-02 00135063702 1 TUBE in 1 CARTON (0135-0637-02) / 22.7 g in 1 TUBE 1 tube 2021-01-04 0000-00-00 No No Current