antiseptic oral rinse

Generic: cetylpyridinium chloride

Labeler: sage products llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antiseptic oral rinse
Generic Name cetylpyridinium chloride
Labeler sage products llc
Dosage Form MOUTHWASH
Routes
BUCCAL
Active Ingredients

cetylpyridinium chloride .5 mg/mL

Manufacturer
Sage Products LLC

Identifiers & Regulatory

Product NDC 53462-175
Product ID 53462-175_4577e9e1-d5a6-a2b1-e063-6394a90a11b7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2000-06-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53462175
Hyphenated Format 53462-175

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 antiseptic oral rinse (source: ndc)
Generic Name cetylpyridinium chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 7 mL in 1 PACKET (53462-175-60)
source: ndc

Packages (1)

Ingredients (1)

cetylpyridinium chloride (.5 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["BUCCAL"], "spl_id": "4577e9e1-d5a6-a2b1-e063-6394a90a11b7", "openfda": {"unii": ["D9OM4SK49P"], "rxcui": ["1251617"], "spl_set_id": ["efff8bae-154d-46bc-8dd4-716800425663"], "manufacturer_name": ["Sage Products LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 mL in 1 PACKET (53462-175-60)", "package_ndc": "53462-175-60", "marketing_start_date": "20011228"}], "brand_name": "Antiseptic Oral Rinse", "product_id": "53462-175_4577e9e1-d5a6-a2b1-e063-6394a90a11b7", "dosage_form": "MOUTHWASH", "product_ndc": "53462-175", "generic_name": "CETYLPYRIDINIUM CHLORIDE", "labeler_name": "Sage Products LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic Oral Rinse", "active_ingredients": [{"name": "CETYLPYRIDINIUM CHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20000621", "listing_expiration_date": "20261231"}