Antiseptic

Product NDC
11673-299
Requested package NDC
11673-299-86
11-digit product format
116730299
Labeler code
11673
Product ID
11673-299_4b1e7970-52da-f36f-e063-6294a90a1627
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Target Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-07-21
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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 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
51d2100a-bbd8-4937-aa2a-a49a1224f43bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-299-862020-01-31C16284748780-19d75b9d1-1b33-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-299-12Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150021
11673-299-77Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50021
11673-299-86Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]5
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-299ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TARGET CORPORATION]19Current NDC, Legacy NDC, 3 package rows20240726_51d2100a-bbd8-4937-aa2a-a49a1224f43b.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
AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation51d2100a-bbd8-4937-aa2a-a49a1224f43b2026-02-18Warnings, Adverse reactionsExact identifier
ndc (package): 11673-299-86
ndc (product): 11673-299
ndc11 (package): 11673029986

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN51d2100a-bbd8-4937-aa2a-a49a1224f43b21
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD51d2100a-bbd8-4937-aa2a-a49a1224f43b21
1100924cetylpyridinium chloride 0.07 % Oral RinseSY51d2100a-bbd8-4937-aa2a-a49a1224f43b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-299-86116730299861000 mL in 1 BOTTLE, PLASTIC (11673-299-86) 1000 ml2023-11-22NoNoCurrent