sensodyne pronamel intensive enamel repair extra fresh

Generic: 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 extra fresh
Generic Name sodium fluoride
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

sodium fluoride .5 mg/mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0451
Product ID 0135-0451_0a03a9b2-cbbd-4b73-91db-aea9d3a32264
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-01-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350451
Hyphenated Format 0135-0451

Supplemental Identifiers

RxCUI
240698
UNII
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 extra fresh (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (0135-0451-01)
source: ndc

Packages (1)

0135-0451-01 500 mL in 1 BOTTLE (0135-0451-01)

Ingredients (1)

sodium fluoride (.5 mg/mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a03a9b2-cbbd-4b73-91db-aea9d3a32264", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["240698"], "spl_set_id": ["817c0dad-d109-428e-adb5-3354604acc94"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (0135-0451-01)", "package_ndc": "0135-0451-01", "marketing_start_date": "20240102"}], "brand_name": "SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh", "product_id": "0135-0451_0a03a9b2-cbbd-4b73-91db-aea9d3a32264", "dosage_form": "LIQUID", "product_ndc": "0135-0451", "generic_name": "sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SENSODYNE PRONAMEL", "brand_name_suffix": "Intensive Enamel Repair Extra Fresh", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".5 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240102", "listing_expiration_date": "20261231"}