sensodyne pronamel intensive enamel repair whitening

Generic: potassium nitrate and 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 intensive enamel repair whitening
Generic Name potassium nitrate and sodium fluoride
Labeler haleon us holdings llc
Dosage Form PASTE
Routes
ORAL
Active Ingredients

potassium nitrate 50 mg/g, sodium fluoride 1.15 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0481
Product ID 0135-0481_4c9ab9d6-fc06-eea3-e063-6394a90a5939
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2027-12-31
Marketing Start 2020-01-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350481
Hyphenated Format 0135-0481

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 intensive enamel repair whitening (source: ndc)
Generic Name potassium nitrate and sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 1.15 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0481-01) / 96.4 g in 1 TUBE
  • 2 TUBE in 1 CARTON (0135-0481-02) / 96.4 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0135-0481-04) / 65 g in 1 TUBE
source: ndc

Packages (3)

0135-0481-01 1 TUBE in 1 CARTON (0135-0481-01) / 96.4 g in 1 TUBE 0135-0481-02 2 TUBE in 1 CARTON (0135-0481-02) / 96.4 g in 1 TUBE 0135-0481-04 1 TUBE in 1 CARTON (0135-0481-04) / 65 g in 1 TUBE

Ingredients (2)

potassium nitrate (50 mg/g) sodium fluoride (1.15 mg/g)

Linked Drug Pages (1)

SENSODYNE PRONAMEL Intensive Enamel Repair Whitening, SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh, SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c9ab9d6-fc06-eea3-e063-6394a90a5939", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1086243"], "spl_set_id": ["a2f9d58b-671b-4427-a971-1fceff5f2323"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0481-01)  / 96.4 g in 1 TUBE", "package_ndc": "0135-0481-01", "marketing_start_date": "20200106"}, {"sample": false, "description": "2 TUBE in 1 CARTON (0135-0481-02)  / 96.4 g in 1 TUBE", "package_ndc": "0135-0481-02", "marketing_start_date": "20200106"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0135-0481-04)  / 65 g in 1 TUBE", "package_ndc": "0135-0481-04", "marketing_start_date": "20251201"}], "brand_name": "SENSODYNE PRONAMEL Intensive Enamel Repair Whitening", "product_id": "0135-0481_4c9ab9d6-fc06-eea3-e063-6394a90a5939", "dosage_form": "PASTE", "product_ndc": "0135-0481", "generic_name": "potassium nitrate and sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SENSODYNE PRONAMEL", "brand_name_suffix": "Intensive Enamel Repair Whitening", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "1.15 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200106", "listing_expiration_date": "20271231"}