FDA.reportPublic FDA data

Antiseptic Oral Rinse

Product NDC
53462-175
11-digit product format
534620175
Labeler code
53462
Product ID
53462-175_4577e9e1-d5a6-a2b1-e063-6394a90a11b7
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
MOUTHWASH
Route
BUCCAL
Labeler
Sage Products LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-06-21
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1251617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-175-302022-02-23C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-302022-02-23C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-602022-02-23C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-602022-02-23C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-302022-01-28C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-302022-01-28C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-602022-01-28C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse
53462-175-602022-01-28C16284748780-1d6a99b39-d057-a426-e053-dadaa90af4c2Antiseptic Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-175-60Antiseptic Oral Rinse7 mL in 1 PACKETMOUTHWASH711
53462-175-60QCare Petite Size Oral Cleansing and Suctioning System7 mL in 1 PACKETMOUTHWASH42 mL in 60.5 mg in 1mL4
53462-175-60Suction Toothbrushes7 mL in 1 PACKETMOUTHWASH7 mL0.5 mg in 1mL3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cetylpyridinium chlorideACTIVE INGREDIENTD9OM4SK49PCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
cetylpyridiniumACTIVE MOIETYCUB7JI0JV3CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
peppermintINACTIVE INGREDIENTV95R5KMY2BCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
sorbitolINACTIVE INGREDIENT506T60A25RCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]2
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-175ANTISEPTIC ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC]9Current NDC, Legacy NDC, 1 package rows20241120_efff8bae-154d-46bc-8dd4-716800425663.zip
53462-175QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]4Current NDC, Legacy NDC20190118_b08bc4f9-85db-b57c-5e1d-97e3383acf18.zip
53462-175SUCTION TOOTHBRUSHES (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]3Current NDC, Legacy NDC20180426_9f81731e-6343-49e0-a2b4-e8269d6bcd6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSNefff8bae-154d-46bc-8dd4-71680042566311
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDefff8bae-154d-46bc-8dd4-71680042566311
1251617cetylpyridinium chloride 0.05 % MouthwashSYefff8bae-154d-46bc-8dd4-71680042566311
1251617cetylpyridinium chloride 0.05 % MouthwashPSNb08bc4f9-85db-b57c-5e1d-97e3383acf184
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDb08bc4f9-85db-b57c-5e1d-97e3383acf184
1251617cetylpyridinium chloride 0.05 % MouthwashSYb08bc4f9-85db-b57c-5e1d-97e3383acf184
1251617cetylpyridinium chloride 0.05 % MouthwashPSN9f81731e-6343-49e0-a2b4-e8269d6bcd6a3
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD9f81731e-6343-49e0-a2b4-e8269d6bcd6a3
1251617cetylpyridinium chloride 0.05 % MouthwashSY9f81731e-6343-49e0-a2b4-e8269d6bcd6a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53462-175-60534620175607 mL in 1 PACKET (53462-175-60) 7 ml2001-12-280000-00-00NoNoCurrent