NDC 52644-001

Oral Defense

Cetylpyridinium Chloride

Oral Defense is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Oral Defense, Llc. The primary component is Cetylpyridinium Chloride.

• Product ID: 52644-001_5acd8ebf-2b8e-40d6-a76d-7bad43ff0658
• NDC: 52644-001
• Product Type: Human Otc Drug
• Proprietary Name: Oral Defense
• Generic Name: Cetylpyridinium Chloride
• Dosage Form: Mouthwash
• Route of Administration: ORAL
• Marketing Start Date: 2010-07-26
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Oral Defense, LLC
• Substance Name: CETYLPYRIDINIUM CHLORIDE
• Active Ingredient Strength: 0 mL/474mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52644-001-02

60 mL in 1 BOTTLE, PLASTIC (52644-001-02)

• Marketing Start Date: 2010-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52644-001-00 [52644000100]

Oral Defense MOUTHWASH

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-07-26
• Inactivation Date: 2019-11-13

NDC 52644-001-02 [52644000102]

Oral Defense MOUTHWASH

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-05-23
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
CETYLPYRIDINIUM CHLORIDE	.47 mL/474mL

OpenFDA Data

• SPL SET ID: 561be134-46d3-416c-becd-1d33388ddd2b
• Manufacturer:
  • Oral Defense, LLC
• UNII:
  • D9OM4SK49P
• RxNorm Concept Unique ID - RxCUI:
  • 1291375

NDC Crossover Matching brand name "Oral Defense" or generic name "Cetylpyridinium Chloride"

NDC	Brand Name	Generic Name
52644-001	Oral Defense	Oral Defense
52644-003	Oral Defense	Oral Defense
11822-5761	Alcohol Free Antiseptic	cetylpyridinium chloride
30142-299	Alcohol Free Antiseptic	cetylpyridinium chloride
0869-0299	Antiseptic	CETYLPYRIDINIUM CHLORIDE
11673-299	Antiseptic	Cetylpyridinium chloride
11822-3724	Antiseptic Night Rinse	Cetylpyridinium Chloride
33992-0320	Assured	Cetylpyridinium Chloride
0126-0023	Colgate Total	CETYLPYRIDINIUM CHLORIDE
0126-0024	Colgate Total	CETYLPYRIDINIUM CHLORIDE
0126-0025	Colgate Total	CETYLPYRIDINIUM CHLORIDE
0126-0026	Colgate Total	CETYLPYRIDINIUM CHLORIDE
35000-720	Colgate Total Advanced Pro-Shield Peppermint Blast	CETYLPYRIDINIUM CHLORIDE
0363-0099	Health	Cetylpyridinium chloride
24765-134	Killfire mouth freshener	Cetylpyridinium Chloride
21130-299	Mint	Cetylpyridinium Chloride
33992-0299	Multi-Action Antiseptic	CETYLPYRIDINIUM CHLORIDE
10237-721	Orajle Anti-Bacterial Rinse for Bleeding Gums	Cetylpyridinium chloride
0041-1420	Oral-B	Cetylpyridinium Chloride
0135-0650	Parodontax	cetylpyridinium chloride
0135-0651	Parodontax	cetylpyridinium chloride
24488-011	Roccos Old School	Cetylpyridinium Chloride
35000-390	Total Advanced Health Fresh Mint	CETYLPYRIDINIUM CHLORIDE