antigingivitis/antiplaque

Generic: cetylpyridinium chloride

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

Drug Facts

Product Profile

Brand Name antigingivitis/antiplaque
Generic Name cetylpyridinium chloride
Labeler topco associates llc
Dosage Form MOUTHWASH
Routes
ORAL
Active Ingredients

cetylpyridinium chloride .5 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-953
Product ID 76162-953_4aba1791-ba47-f1f3-e063-6394a90a55f2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2024-04-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162953
Hyphenated Format 76162-953

Supplemental Identifiers

RxCUI
1251617
UNII
D9OM4SK49P

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 antigingivitis/antiplaque (source: ndc)
Generic Name cetylpyridinium chloride (source: ndc)
Application Number M505G(a)(3) (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1000 mL in 1 BOTTLE, PLASTIC (76162-953-86)
source: ndc

Packages (1)

76162-953-86 1000 mL in 1 BOTTLE, PLASTIC (76162-953-86)

Ingredients (1)

cetylpyridinium chloride (.5 mg/mL)

Linked Drug Pages (1)

Antigingivitis/Antiplaque ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4aba1791-ba47-f1f3-e063-6394a90a55f2", "openfda": {"unii": ["D9OM4SK49P"], "rxcui": ["1251617"], "spl_set_id": ["3fefe9b3-d61d-494d-bd85-5d2cf8321398"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (76162-953-86)", "package_ndc": "76162-953-86", "marketing_start_date": "20240418"}], "brand_name": "Antigingivitis/Antiplaque", "product_id": "76162-953_4aba1791-ba47-f1f3-e063-6394a90a55f2", "dosage_form": "MOUTHWASH", "product_ndc": "76162-953", "generic_name": "Cetylpyridinium Chloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antigingivitis/Antiplaque", "active_ingredients": [{"name": "CETYLPYRIDINIUM CHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240418", "listing_expiration_date": "20271231"}