sensodyne pronamel clinical enamel strength fresh breath

Generic: potassium nitrate, sodium fluoride

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

Drug Facts

Product Profile

Brand Name sensodyne pronamel clinical enamel strength fresh breath
Generic Name potassium nitrate, sodium fluoride
Labeler haleon us holdings llc
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 50 mg/g, sodium fluoride 1.5 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-7753
Product ID 0135-7753_42f3ff91-2b4f-ec25-e063-6294a90a250e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01357753
Hyphenated Format 0135-7753

Supplemental Identifiers

RxCUI
1086243
UNII
RU45X2JN0Z 8ZYQ1474W7

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 sensodyne pronamel clinical enamel strength fresh breath (source: ndc)
Generic Name potassium nitrate, sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 1.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-7753-01) / 96.4 g in 1 TUBE
source: ndc

Packages (1)

0135-7753-01 1 TUBE in 1 CARTON (0135-7753-01) / 96.4 g in 1 TUBE

Ingredients (2)

potassium nitrate (50 mg/g) sodium fluoride (1.5 mg/g)

Linked Drug Pages (1)

Sensodyne Pronamel Clinical Enamel Strength Fresh Breath ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "42f3ff91-2b4f-ec25-e063-6294a90a250e", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1086243"], "spl_set_id": ["34a1a32e-3017-f018-e063-6394a90a0230"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-7753-01)  / 96.4 g in 1 TUBE", "package_ndc": "0135-7753-01", "marketing_start_date": "20251201"}], "brand_name": "Sensodyne Pronamel Clinical Enamel Strength Fresh Breath", "product_id": "0135-7753_42f3ff91-2b4f-ec25-e063-6294a90a250e", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "0135-7753", "generic_name": "potassium nitrate, sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sensodyne", "brand_name_suffix": "Pronamel Clinical Enamel Strength Fresh Breath", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "1.5 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}