aquafresh sensitive maximum strength

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 aquafresh sensitive maximum strength
Generic Name potassium nitrate and sodium fluoride
Labeler haleon us holdings llc
Dosage Form PASTE
Routes
DENTAL
Active Ingredients

potassium nitrate 50 mg/g, sodium fluoride 1.1 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0605
Product ID 0135-0605_0e988328-62da-43e7-98b3-5d94a4cd6684
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2017-02-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350605
Hyphenated Format 0135-0605

Supplemental Identifiers

RxCUI
1038929
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 aquafresh sensitive maximum strength (source: ndc)
Generic Name potassium nitrate and sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 1.1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0605-01) / 158.8 g in 1 TUBE
source: ndc

Packages (1)

0135-0605-01 1 TUBE in 1 CARTON (0135-0605-01) / 158.8 g in 1 TUBE

Ingredients (2)

potassium nitrate (50 mg/g) sodium fluoride (1.1 mg/g)

Linked Drug Pages (1)

AQUAFRESH SENSITIVE MAXIMUM STRENGTH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "0e988328-62da-43e7-98b3-5d94a4cd6684", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1038929"], "spl_set_id": ["76adbccb-0812-4407-a6fc-a57e6f144fbb"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0605-01)  / 158.8 g in 1 TUBE", "package_ndc": "0135-0605-01", "marketing_start_date": "20170217"}], "brand_name": "AQUAFRESH SENSITIVE MAXIMUM STRENGTH", "product_id": "0135-0605_0e988328-62da-43e7-98b3-5d94a4cd6684", "dosage_form": "PASTE", "product_ndc": "0135-0605", "generic_name": "potassium nitrate and sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AQUAFRESH", "brand_name_suffix": "SENSITIVE MAXIMUM STRENGTH", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170217", "listing_expiration_date": "20261231"}