orapro fluoride anticavity

Generic: fluoride toothpaste

Labeler: protegera, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name orapro fluoride anticavity
Generic Name fluoride toothpaste
Labeler protegera, inc.
Dosage Form PASTE, DENTIFRICE
Routes
ORAL
Active Ingredients

sodium fluoride 1.4 mg/g

Manufacturer
Protegera, Inc.

Identifiers & Regulatory

Product NDC 83610-1060
Product ID 83610-1060_3995ff67-0795-cc1d-e063-6394a90af7ff
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 836101060
Hyphenated Format 83610-1060

Supplemental Identifiers

RxCUI
416783
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 orapro fluoride anticavity (source: ndc)
Generic Name fluoride toothpaste (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (83610-1060-1) / 147 g in 1 TUBE
source: ndc

Packages (1)

83610-1060-1 1 TUBE in 1 CARTON (83610-1060-1) / 147 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.4 mg/g)

Linked Drug Pages (1)

OraPro Fluoride Anticavity ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3995ff67-0795-cc1d-e063-6394a90af7ff", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["93b0181c-e29f-42f4-80f5-366463b68f09"], "manufacturer_name": ["Protegera, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (83610-1060-1)  / 147 g in 1 TUBE", "package_ndc": "83610-1060-1", "marketing_start_date": "20250630"}], "brand_name": "OraPro Fluoride Anticavity", "product_id": "83610-1060_3995ff67-0795-cc1d-e063-6394a90af7ff", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "83610-1060", "generic_name": "Fluoride Toothpaste", "labeler_name": "Protegera, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OraPro Fluoride Anticavity", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.4 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}