FDA.reportPublic FDA data

Alcohol Free

Product NDC
37808-299
11-digit product format
378080299
Labeler code
37808
Product ID
37808-299_5111c810-a771-9843-e063-6394a90a090c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium cloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-04-16
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
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
9787c416-e2c6-49f9-817f-ef1df3857583Available 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
37808-299-86Alcohol Free1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3ALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1
WATERINACTIVE INGREDIENT059QF0KO0RALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-299ALCOHOL FREE (CETYLPYRIDINIUM CLORIDE) MOUTHWASH [H-E-B]13Current NDC, Legacy NDC, 1 package rows20240922_9787c416-e2c6-49f9-817f-ef1df3857583.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 FreeCETYLPYRIDINIUM CLORIDEH E B9787c416-e2c6-49f9-817f-ef1df38575832026-05-05Warnings, Adverse reactionsExact identifier
ndc (product): 37808-299

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN9787c416-e2c6-49f9-817f-ef1df385758316
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD9787c416-e2c6-49f9-817f-ef1df385758316
1100924cetylpyridinium chloride 0.07 % Oral RinseSY9787c416-e2c6-49f9-817f-ef1df385758316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-299-86378080299861000 mL in 1 BOTTLE, PLASTIC (37808-299-86) 1000 ml2009-04-160000-00-00NoNoCurrent