FDA.reportPublic FDA data

Alcohol Free Antiseptic

Product NDC
11822-5761
11-digit product format
118225761
Labeler code
11822
Product ID
11822-5761_49a0328d-3c54-9132-e063-6294a90aeb02
Type
HUMAN OTC DRUG
Nonproprietary name
cetylpyridinium chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-16
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 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
Alcohol Free Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 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
1100924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69b8649b-1876-4c3a-a64d-5476edbe0a4aAvailable 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
11822-5761-2Alcohol Free Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5761ALCOHOL FREE ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [RITE AID]8Current NDC, Legacy NDC, 1 package rows20250121_69b8649b-1876-4c3a-a64d-5476edbe0a4a.zip

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
Alcohol Free AntisepticCETYLPYRIDINIUM CHLORIDERite Aid Corporation69b8649b-1876-4c3a-a64d-5476edbe0a4a2026-01-30Warnings, Adverse reactionsExact identifier
ndc (product): 11822-5761

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN69b8649b-1876-4c3a-a64d-5476edbe0a4a9
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD69b8649b-1876-4c3a-a64d-5476edbe0a4a9
1100924cetylpyridinium chloride 0.07 % Oral RinseSY69b8649b-1876-4c3a-a64d-5476edbe0a4a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5761-2118225761021000 mL in 1 BOTTLE, PLASTIC (11822-5761-2) 1000 ml2019-12-160000-00-00NoNoCurrent