Cetylpyridinium Chloride

Product NDC
75712-542
Requested package NDC
75712-542-38
11-digit product format
757120542
Labeler code
75712
Product ID
75712-542_5df841cc-59a6-0148-e063-6294a90abfec
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Old East Main Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-16
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cetylpyridinium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 mg/mL

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-542-3875712054238296 mL in 1 BOTTLE, PLASTIC (75712-542-38) 296 ml2026-10-16NoNoCurrent