FDA.reportPublic FDA data

Antiseptic

Product NDC
50804-299
11-digit product format
508040299
Labeler code
50804
Product ID
50804-299_4b3109c5-ee75-3105-e063-6394a90af028
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Perrigo Direct, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-09-20
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticCETYLPYRIDINIUM CHLORIDEPerrigo Direct, Inc4d452c85-8e28-4915-a638-c71fc9cc77d62026-02-19Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings for this product Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTION Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com 1-888-593-0593 GoodSense is a registered trademark of L. Perrigo Company.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1100924

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-299-862022-10-05C16284748780-1ba0f9c33-486f-a910-e053-dadaa90a0b85Good Sense 299.005/299AK-AL Multi Action Alcohol Free Antiseptic Rinse w/CPC
50804-299-862021-01-29C16284748780-1ba0f9c33-486f-a910-e053-dadaa90a0b85Good Sense 299.005/299AK-AL Multi Action Alcohol Free Antiseptic Rinse w/CPC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-299-86Antiseptic1000 mL in 1 BOTTLE, PLASTICRINSE100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-299-86ML - Milliliter50804-299ca8d3974-c7ac-4751-9a32-927c45f8f6ae12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-299ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [PERRIGO DIRECT, INC]16Current NDC, Legacy NDC, 1 package rows20240920_4d452c85-8e28-4915-a638-c71fc9cc77d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN4d452c85-8e28-4915-a638-c71fc9cc77d618
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD4d452c85-8e28-4915-a638-c71fc9cc77d618
1100924cetylpyridinium chloride 0.07 % Oral RinseSY4d452c85-8e28-4915-a638-c71fc9cc77d618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-299-86508040299861000 mL in 1 BOTTLE, PLASTIC (50804-299-86) 1000 ml1993-09-200000-00-00NoNoCurrent