parodontax active gum repair whitening

Generic: stannous fluoride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name parodontax active gum repair whitening
Generic Name stannous fluoride
Labeler haleon us holdings llc
Dosage Form PASTE
Routes
DENTAL
Active Ingredients

stannous fluoride 1.1 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0638
Product ID 0135-0638_7483472a-9e10-436c-aa9f-abe78b3f2d75
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2022-01-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350638
Hyphenated Format 0135-0638

Supplemental Identifiers

RxCUI
416784
UNII
3FTR44B32Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name parodontax active gum repair whitening (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1.1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0638-03) / 65.2 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0135-0638-04) / 96.4 g in 1 TUBE
  • 2 TUBE in 1 CARTON (0135-0638-06) / 96.4 g in 1 TUBE
source: ndc

Packages (3)

0135-0638-03 1 TUBE in 1 CARTON (0135-0638-03) / 65.2 g in 1 TUBE 0135-0638-04 1 TUBE in 1 CARTON (0135-0638-04) / 96.4 g in 1 TUBE 0135-0638-06 2 TUBE in 1 CARTON (0135-0638-06) / 96.4 g in 1 TUBE

Ingredients (1)

stannous fluoride (1.1 mg/g)

Linked Drug Pages (1)

parodontax Active Gum Repair Whitening ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "7483472a-9e10-436c-aa9f-abe78b3f2d75", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["416784"], "spl_set_id": ["817e804c-e55e-4d77-9ab9-ff54ae794725"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0638-03)  / 65.2 g in 1 TUBE", "package_ndc": "0135-0638-03", "marketing_start_date": "20220103"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0135-0638-04)  / 96.4 g in 1 TUBE", "package_ndc": "0135-0638-04", "marketing_start_date": "20220103"}, {"sample": false, "description": "2 TUBE in 1 CARTON (0135-0638-06)  / 96.4 g in 1 TUBE", "package_ndc": "0135-0638-06", "marketing_start_date": "20250401"}], "brand_name": "parodontax Active Gum Repair Whitening", "product_id": "0135-0638_7483472a-9e10-436c-aa9f-abe78b3f2d75", "dosage_form": "PASTE", "product_ndc": "0135-0638", "generic_name": "stannous fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "parodontax", "brand_name_suffix": "Active Gum Repair Whitening", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220103", "listing_expiration_date": "20261231"}