NDC 54473-294

BreathAway Mouth Rinse Fresh Mint

Cetylpyridinium Chloride

BreathAway Mouth Rinse Fresh Mint is a Topical Mouthwash in the Human Otc Drug category. It is labeled and distributed by Melaleuca, Inc.. The primary component is Cetylpyridinium Chloride.

Product ID54473-294_65e42ef2-d04b-6174-e053-2991aa0a9830
NDC54473-294
Product TypeHuman Otc Drug
Proprietary NameBreathAway Mouth Rinse Fresh Mint
Generic NameCetylpyridinium Chloride
Dosage FormMouthwash
Route of AdministrationTOPICAL
Marketing Start Date2011-05-02
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameMelaleuca, Inc.
Substance NameCETYLPYRIDINIUM CHLORIDE
Active Ingredient Strength0 g/473mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54473-294-08

237 mL in 1 BOTTLE (54473-294-08)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54473-294-16 [54473029416]

BreathAway Mouth Rinse Fresh Mint MOUTHWASH
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31
Reactivation Date2020-03-19

NDC 54473-294-08 [54473029408]

BreathAway Mouth Rinse Fresh Mint MOUTHWASH
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31
Reactivation Date2020-03-19

Drug Details

Active Ingredients

IngredientStrength
CETYLPYRIDINIUM CHLORIDE.3394 g/473mL

OpenFDA Data

SPL SET ID:37b2c031-ecc9-4420-9d84-e71c0e529187
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100928
  • 1100924
  • NDC Crossover Matching brand name "BreathAway Mouth Rinse Fresh Mint" or generic name "Cetylpyridinium Chloride"

    NDCBrand NameGeneric Name
    54473-294BreathAway Mouth Rinse Fresh MintBreathAway Mouth Rinse Fresh Mint
    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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