made by dentists enamel rebuilding professional

Generic: potassium nitrate, sodium fluoride

Labeler: fulijaya manufacturing sdn. bhd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name made by dentists enamel rebuilding professional
Generic Name potassium nitrate, sodium fluoride
Labeler fulijaya manufacturing sdn. bhd
Dosage Form PASTE
Routes
DENTAL
Active Ingredients

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

Manufacturer
Fulijaya Manufacturing Sdn. Bhd

Identifiers & Regulatory

Product NDC 62776-003
Product ID 62776-003_383e8249-c326-68b6-e063-6294a90a17cd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62776003
Hyphenated Format 62776-003

Supplemental Identifiers

RxCUI
1038929
UPC
0850031970717
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 made by dentists enamel rebuilding professional (source: ndc)
Generic Name potassium nitrate, sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 1.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (62776-003-01) / 120 g in 1 TUBE
source: ndc

Packages (1)

62776-003-01 1 TUBE in 1 CARTON (62776-003-01) / 120 g in 1 TUBE

Ingredients (2)

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

Linked Drug Pages (1)

Made by Dentists Enamel Rebuilding Professional ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "383e8249-c326-68b6-e063-6294a90a17cd", "openfda": {"upc": ["0850031970717"], "unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1038929"], "spl_set_id": ["178d7538-c178-b8ca-e063-6394a90a7d33"], "manufacturer_name": ["Fulijaya Manufacturing Sdn. Bhd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (62776-003-01)  / 120 g in 1 TUBE", "package_ndc": "62776-003-01", "marketing_start_date": "20240101"}], "brand_name": "Made by Dentists Enamel Rebuilding Professional", "product_id": "62776-003_383e8249-c326-68b6-e063-6294a90a17cd", "dosage_form": "PASTE", "product_ndc": "62776-003", "generic_name": "POTASSIUM NITRATE, SODIUM FLUORIDE", "labeler_name": "Fulijaya Manufacturing Sdn. Bhd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Made by Dentists Enamel Rebuilding Professional", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "1.5 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}