NDC 53462-175

Antiseptic Oral Rinse

Cetylpyridinium Chloride

Antiseptic Oral Rinse is a Buccal Mouthwash in the Human Otc Drug category. It is labeled and distributed by Sage Products Llc. The primary component is Cetylpyridinium Chloride.

Product ID53462-175_6a4a7dd7-5b0f-4012-e053-2991aa0a7ddb
NDC53462-175
Product TypeHuman Otc Drug
Proprietary NameAntiseptic Oral Rinse
Generic NameCetylpyridinium Chloride
Dosage FormMouthwash
Route of AdministrationBUCCAL
Marketing Start Date2000-06-21
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameSage Products LLC
Substance NameCETYLPYRIDINIUM CHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53462-175-60

7 mL in 1 PACKET (53462-175-60)
Marketing Start Date2001-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53462-175-30 [53462017530]

Antiseptic Oral Rinse MOUTHWASH
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2000-06-21
Marketing End Date2018-04-09

NDC 53462-175-60 [53462017560]

Antiseptic Oral Rinse MOUTHWASH
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-12-28

Drug Details

Active Ingredients

IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:efff8bae-154d-46bc-8dd4-716800425663
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251617

    • NDC Crossover Matching brand name "Antiseptic Oral Rinse" or generic name "Cetylpyridinium Chloride"

    NDCBrand NameGeneric Name
    53462-175Antiseptic Oral RinseAntiseptic Oral Rinse
    67618-182Antiseptic Oral RinseAntiseptic Oral Rinse
    11822-5761Alcohol Free Antisepticcetylpyridinium chloride
    30142-299Alcohol Free Antisepticcetylpyridinium chloride
    0869-0299AntisepticCETYLPYRIDINIUM CHLORIDE
    11673-299AntisepticCetylpyridinium chloride
    11822-3724Antiseptic Night RinseCetylpyridinium Chloride
    33992-0320AssuredCetylpyridinium Chloride
    0126-0023Colgate TotalCETYLPYRIDINIUM CHLORIDE
    0126-0024Colgate TotalCETYLPYRIDINIUM CHLORIDE
    0126-0025Colgate TotalCETYLPYRIDINIUM CHLORIDE
    0126-0026Colgate TotalCETYLPYRIDINIUM CHLORIDE
    35000-720Colgate Total Advanced Pro-Shield Peppermint BlastCETYLPYRIDINIUM CHLORIDE
    0363-0099HealthCetylpyridinium chloride
    24765-134Killfire mouth freshenerCetylpyridinium Chloride
    21130-299MintCetylpyridinium Chloride
    33992-0299Multi-Action AntisepticCETYLPYRIDINIUM CHLORIDE
    10237-721Orajle Anti-Bacterial Rinse for Bleeding GumsCetylpyridinium chloride
    0041-1420Oral-BCetylpyridinium Chloride
    0135-0650Parodontaxcetylpyridinium chloride
    0135-0651Parodontaxcetylpyridinium chloride
    24488-011Roccos Old SchoolCetylpyridinium Chloride
    35000-390Total Advanced Health Fresh MintCETYLPYRIDINIUM CHLORIDE
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