colgate optic white pro series

Generic: sodium monofluorophosphate

Labeler: mission hills, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name colgate optic white pro series
Generic Name sodium monofluorophosphate
Labeler mission hills, s.a. de c.v.
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium monofluorophosphate 11.4 mg/g

Manufacturer
Mission Hills, S.A. de C.V.

Identifiers & Regulatory

Product NDC 65954-845
Product ID 65954-845_fad24e59-3511-4b57-a986-11c1409e25a8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2025-11-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65954845
Hyphenated Format 65954-845

Supplemental Identifiers

RxCUI
1038995
UPC
0827854028468
UNII
C810JCZ56Q

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 colgate optic white pro series (source: ndc)
Generic Name sodium monofluorophosphate (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 11.4 mg/g
source: ndc
Packaging
  • 2 TUBE in 1 CARTON (65954-845-62) / 85 g in 1 TUBE
  • 1 TUBE in 1 CARTON (65954-845-63) / 85 g in 1 TUBE
source: ndc

Packages (2)

Ingredients (1)

sodium monofluorophosphate (11.4 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["DENTAL"], "spl_id": "fad24e59-3511-4b57-a986-11c1409e25a8", "openfda": {"upc": ["0827854028468"], "unii": ["C810JCZ56Q"], "rxcui": ["1038995"], "spl_set_id": ["a48e83ae-a02a-4a6d-a601-7acaba3bbbc9"], "manufacturer_name": ["Mission Hills, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (65954-845-62)  / 85 g in 1 TUBE", "package_ndc": "65954-845-62", "marketing_start_date": "20251124"}, {"sample": false, "description": "1 TUBE in 1 CARTON (65954-845-63)  / 85 g in 1 TUBE", "package_ndc": "65954-845-63", "marketing_start_date": "20251124"}], "brand_name": "COLGATE OPTIC WHITE PRO SERIES", "product_id": "65954-845_fad24e59-3511-4b57-a986-11c1409e25a8", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "65954-845", "generic_name": "SODIUM MONOFLUOROPHOSPHATE", "labeler_name": "Mission Hills, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLGATE OPTIC WHITE PRO SERIES", "active_ingredients": [{"name": "SODIUM MONOFLUOROPHOSPHATE", "strength": "11.4 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251124", "listing_expiration_date": "20261231"}