FDA.reportPublic FDA data

Corinz

Product NDC
53462-375
11-digit product format
534620375
Labeler code
53462
Product ID
53462-375_45782773-1642-fa67-e063-6394a90a23e4
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Corinz
Listing expiration
2026-12-31

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
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-375-072022-02-22C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®
53462-375-302022-02-22C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®
53462-375-602022-02-22C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®
53462-375-072022-01-28C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®
53462-375-302022-01-28C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®
53462-375-602022-01-28C16284748780-1d6a99b39-6723-a426-e053-dadaa90af4c2Corinz®

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

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