Cetylpyridinium Chloride

Product NDC
0363-9542
11-digit product format
003639542
Labeler code
0363
Product ID
0363-9542_4a8dd6f6-09ac-5fab-e063-6394a90a7342
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreen Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-11
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1251617Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476df2f5-42fa-edc2-e063-6294a90a7b5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9542-43Cetylpyridinium Chloride473 mL in 1 BOTTLE, PLASTICLIQUID4732

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetylpyridinium ChlorideCETYLPYRIDINIUM CHLORIDEWalgreen Co.476df2f5-42fa-edc2-e063-6294a90a7b5c2026-02-11Warnings, Adverse reactionsExact identifier
ndc (product): 0363-9542

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN476df2f5-42fa-edc2-e063-6294a90a7b5c2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD476df2f5-42fa-edc2-e063-6294a90a7b5c2
1251617cetylpyridinium chloride 0.05 % MouthwashSY476df2f5-42fa-edc2-e063-6294a90a7b5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9542-4300363954243473 mL in 1 BOTTLE, PLASTIC (0363-9542-43) 473 ml2026-02-11NoNoCurrent