pro gel 5000 citrus

Generic: sodium fluoride

Labeler: dental alliance holdings llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name pro gel 5000 citrus
Generic Name sodium fluoride
Labeler dental alliance holdings llc
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride 5000 ug/g

Manufacturer
DENTAL ALLIANCE HOLDINGS LLC

Identifiers & Regulatory

Product NDC 61578-216
Product ID 61578-216_424ae751-1f8e-4e67-ba2e-b368d447053e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2022-05-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61578216
Hyphenated Format 61578-216

Supplemental Identifiers

RxCUI
392038
UPC
0361578216010 0361578215013
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 pro gel 5000 citrus (source: ndc)
Generic Name sodium fluoride (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 5000 ug/g
source: ndc
Packaging
  • 68 g in 1 TUBE, WITH APPLICATOR (61578-216-01)
source: ndc

Packages (1)

61578-216-01 68 g in 1 TUBE, WITH APPLICATOR (61578-216-01)

Ingredients (1)

sodium fluoride (5000 ug/g)

Linked Drug Pages (1)

PRO Gel 5000 Mint, PRO Gel 5000 Citrus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "424ae751-1f8e-4e67-ba2e-b368d447053e", "openfda": {"upc": ["0361578216010", "0361578215013"], "unii": ["8ZYQ1474W7"], "rxcui": ["392038"], "spl_set_id": ["f127e236-5207-948b-e053-2a95a90ab740"], "manufacturer_name": ["DENTAL ALLIANCE HOLDINGS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "68 g in 1 TUBE, WITH APPLICATOR (61578-216-01)", "package_ndc": "61578-216-01", "marketing_start_date": "20220510"}], "brand_name": "PRO Gel 5000 Citrus", "product_id": "61578-216_424ae751-1f8e-4e67-ba2e-b368d447053e", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "61578-216", "generic_name": "Sodium fluoride", "labeler_name": "DENTAL ALLIANCE HOLDINGS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRO Gel 5000", "brand_name_suffix": "Citrus", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "5000 ug/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20220510", "listing_expiration_date": "20261231"}