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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact 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