FDA.reportPublic FDA data

Corinz

Product NDC
53462-375
11-digit product format
534620375
Labeler code
53462
Product ID
53462-375_5568e55e-72ac-77a0-e063-6294a90a0273
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
RINSE
Route
ORAL
Labeler
Sage Products, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-20
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
Corinz
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
685b6023-89c4-417e-af2d-52e831855da1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53462-375-072022-02-22Corinz®
53462-375-072022-02-22Corinz®
53462-375-302022-02-22Corinz®
53462-375-302022-02-22Corinz®
53462-375-602022-02-22Corinz®
53462-375-602022-02-22Corinz®
53462-375-072022-01-28Corinz®
53462-375-072022-01-28Corinz®
53462-375-302022-01-28Corinz®
53462-375-302022-01-28Corinz®
53462-375-602022-01-28Corinz®
53462-375-602022-01-28Corinz®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-375-07Corinz7 mL in 1 CUPRINSE716
53462-375-30Corinz44 mL in 1 BOTTLERINSE4416
53462-375-60Corinz7 mL in 1 PACKETRINSE716
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL5
53462-375-60Suction Swab with Corinz Oral Rinse7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL2
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL2
53462-375-60Suction Toothbrush with Corinz Oral Rinse7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL2
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System1 in 1 KITRINSE0.5 mg in 1mL2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL45QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EQCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-375CORINZ (CETYLPYRIDINIUM CHLORIDE) RINSE [SAGE PRODUCTS, LLC]14Current NDC, Legacy NDC, 3 package rows20241116_685b6023-89c4-417e-af2d-52e831855da1.zip
53462-375SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]5Current NDC, Legacy NDC20190725_46f82c35-88bb-4f06-abf4-5250e7173aa6.zip
53462-375SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20170207_a12eefb3-1130-4644-895e-d219613d7e41.zip
53462-375SUCTION SWAB WITH CORINZ ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20180403_e0b2244b-9a34-4d58-a0c9-d49f308f7797.zip
53462-375SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20180403_a2a9a88e-3a51-479d-b867-dd1d1355dc88.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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moon Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
application number: M022
ORCA Complete Menthol Pain RelieverMENTHOLORCA Products, LLC99990e27-d66b-4d61-97f2-6a76066eb8b82023-12-08WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc0070858b-e02e-431f-a7c2-313fef01791b2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incd1802f08-80cb-41dd-b34d-9c576b101ddb2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN685b6023-89c4-417e-af2d-52e831855da116
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD685b6023-89c4-417e-af2d-52e831855da116
1251617cetylpyridinium chloride 0.05 % MouthwashSY685b6023-89c4-417e-af2d-52e831855da116
1251617cetylpyridinium chloride 0.05 % MouthwashPSN46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 2 % Medicated PadPSN46f82c35-88bb-4f06-abf4-5250e7173aa65
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCD46f82c35-88bb-4f06-abf4-5250e7173aa65
1251617cetylpyridinium chloride 0.05 % MouthwashSY46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 2 % Medicated PadSY46f82c35-88bb-4f06-abf4-5250e7173aa65
1251617cetylpyridinium chloride 0.05 % MouthwashPSN69dc3f73-5992-45d2-95cc-3ba5dd40b4703
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD69dc3f73-5992-45d2-95cc-3ba5dd40b4703
1251617cetylpyridinium chloride 0.05 % MouthwashSY69dc3f73-5992-45d2-95cc-3ba5dd40b4703
1251617cetylpyridinium chloride 0.05 % MouthwashPSNe0b2244b-9a34-4d58-a0c9-d49f308f77972
1251617cetylpyridinium chloride 0.05 % MouthwashPSNa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.05 % MouthwashPSNa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
1251617cetylpyridinium chloride 0.05 % MouthwashPSNa2a9a88e-3a51-479d-b867-dd1d1355dc882
1251617cetylpyridinium chloride 0.05 % MouthwashPSNd56b7b37-f818-4e7f-9443-3bf7e5a530ee2
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionPSNa2a9a88e-3a51-479d-b867-dd1d1355dc882
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionPSNe0b2244b-9a34-4d58-a0c9-d49f308f77972
834127chlorhexidine gluconate 0.12 % Oral RinsePSNa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
846127chlorhexidine gluconate 2 % Medicated PadPSNa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 5 % Topical SolutionPSNa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDd56b7b37-f818-4e7f-9443-3bf7e5a530ee2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDa2a9a88e-3a51-479d-b867-dd1d1355dc882
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDe0b2244b-9a34-4d58-a0c9-d49f308f77972
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
1251788cetylpyridinium chloride 0.5 MG/ML Mucous Membrane Topical SolutionSCDe0b2244b-9a34-4d58-a0c9-d49f308f77972
1251788cetylpyridinium chloride 0.5 MG/ML Mucous Membrane Topical SolutionSCDa2a9a88e-3a51-479d-b867-dd1d1355dc882
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCDa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 50 MG/ML Topical SolutionSCDa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.05 % MouthwashSYd56b7b37-f818-4e7f-9443-3bf7e5a530ee2
1251617cetylpyridinium chloride 0.05 % MouthwashSYe0b2244b-9a34-4d58-a0c9-d49f308f77972
1251617cetylpyridinium chloride 0.05 % MouthwashSYa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.05 % MouthwashSYa2a9a88e-3a51-479d-b867-dd1d1355dc882
1251617cetylpyridinium chloride 0.05 % MouthwashSYa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionSYa2a9a88e-3a51-479d-b867-dd1d1355dc882
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionSYe0b2244b-9a34-4d58-a0c9-d49f308f77972
834127chlorhexidine gluconate 0.12 % MouthwashSYa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
834127chlorhexidine gluconate 0.12 % Oral RinseSYa1dfbb2f-08dd-4c9e-9d4e-7cea138b55132
846127chlorhexidine gluconate 2 % Medicated PadSYa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSYa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.05 % MouthwashPSN08560105-d7fc-334e-08a1-73c0f1f93b7b1
1251617cetylpyridinium chloride 0.05 % MouthwashPSNc19efc08-23c2-7cf4-c1a8-f072e43332b91
834127chlorhexidine gluconate 0.12 % Oral RinsePSNc19efc08-23c2-7cf4-c1a8-f072e43332b91
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDc19efc08-23c2-7cf4-c1a8-f072e43332b91
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD08560105-d7fc-334e-08a1-73c0f1f93b7b1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDc19efc08-23c2-7cf4-c1a8-f072e43332b91
1251617cetylpyridinium chloride 0.05 % MouthwashSYc19efc08-23c2-7cf4-c1a8-f072e43332b91
1251617cetylpyridinium chloride 0.05 % MouthwashSY08560105-d7fc-334e-08a1-73c0f1f93b7b1
834127chlorhexidine gluconate 0.12 % MouthwashSYc19efc08-23c2-7cf4-c1a8-f072e43332b91
834127chlorhexidine gluconate 0.12 % Oral RinseSYc19efc08-23c2-7cf4-c1a8-f072e43332b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53462-375-07534620375077 mL in 1 CUP (53462-375-07) 7 ml2019-07-220000-00-00NoNoCurrent
53462-375-305346203753044 mL in 1 BOTTLE (53462-375-30) 44 ml2017-04-070000-00-00NoNoCurrent
53462-375-60534620375607 mL in 1 PACKET (53462-375-60) 7 ml2015-01-200000-00-00NoNoCurrent