FDA.reportPublic FDA data

Antiseptic Oral Rinse

Product NDC
53462-175
11-digit product format
534620175
Labeler code
53462
Product ID
53462-175_55068435-9db1-0599-e063-6294a90abea5
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
1251617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efff8bae-154d-46bc-8dd4-716800425663Available on FDA.report

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, Related label table
NDCEffectiveRelated label
53462-175-302022-02-23Antiseptic Oral Rinse
53462-175-302022-02-23Antiseptic Oral Rinse
53462-175-602022-02-23Antiseptic Oral Rinse
53462-175-602022-02-23Antiseptic Oral Rinse
53462-175-302022-01-28Antiseptic Oral Rinse
53462-175-302022-01-28Antiseptic Oral Rinse
53462-175-602022-01-28Antiseptic Oral Rinse
53462-175-602022-01-28Antiseptic 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

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 4 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Mint JulepGINGICAINE GEL, MINT JULEP FLABVORGingi-Pak a Division of the Belport6285fe10-08ba-8044-e053-2991aa0a8e8b2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
ndc (product): 53462-175
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022

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