topco associates llc maximum strength

Generic: fluoride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topco associates llc maximum strength
Generic Name fluoride
Labeler topco associates llc
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 5 g/100g, sodium fluoride .15 g/100g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-364
Product ID 36800-364_47e514c6-af35-cdd8-e063-6394a90aea44
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2027-12-31
Marketing Start 2025-06-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800364
Hyphenated Format 36800-364

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 topco associates llc maximum strength (source: ndc)
Generic Name fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
  • .15 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-364-10) / 113 g in 1 TUBE
source: ndc

Packages (1)

36800-364-10 1 TUBE in 1 CARTON (36800-364-10) / 113 g in 1 TUBE

Ingredients (2)

potassium nitrate (5 g/100g) sodium fluoride (.15 g/100g)

Linked Drug Pages (1)

Topco Associates LLC Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "47e514c6-af35-cdd8-e063-6394a90aea44", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1038929"], "spl_set_id": ["387d264c-90cc-5e67-e063-6394a90a713d"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-364-10)  / 113 g in 1 TUBE", "package_ndc": "36800-364-10", "marketing_start_date": "20250626"}], "brand_name": "Topco Associates LLC Maximum Strength", "product_id": "36800-364_47e514c6-af35-cdd8-e063-6394a90aea44", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "36800-364", "generic_name": "Fluoride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topco Associates LLC", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "5 g/100g"}, {"name": "SODIUM FLUORIDE", "strength": ".15 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250626", "listing_expiration_date": "20271231"}