FDA.reportPublic FDA data

Suction Toothbrush with Corinz Oral Rinse

Manufacturer
Sage Products, LLC
Effective date
2018-04-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:08

Label at a glance#

ProductSuction Toothbrush with Corinz Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Dosage and administration

Use up to 4 time daily or as directed by a dentist or doctor. Adults and children 3 years and older: rinse mouth with 1/2 Tbsp. for approx. one minute. Instruct to expectorate. Children under 3 years of age: consult a doctor.

Label contents#

Full prescribing information#

Use

OTC - WHEN USING SECTION

Helps reduce chance of infection in minor oral irritation.

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

 Active Ingredient:    Purpose
 Cetylpyridinium chloride 0.05% Antiseptic Rinse

Warnings

WARNINGS SECTION

Stop use and ask a doctor if:


  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

OTC - PURPOSE SECTION

  • Use up to 4 time daily or as directed by a dentist or doctor.
  • Adults and children 3 years and older: rinse mouth with 1/2 Tbsp. for approx. one minute. Instruct to expectorate.
  • Children under 3 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80m, hyrdroxyethylcellulose, citric acid, sodium saccharin, menthol.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800-323-2220

SPL UNCLASSIFIED SECTION

NOT MADE WITH NATURAL RUBBER LATEX 

MADE IN USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6561 label6561 label

Corinz packetCorinz packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN2
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionPSN2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD2
1251788cetylpyridinium chloride 0.5 MG/ML Mucous Membrane Topical SolutionSCD2
1251617cetylpyridinium chloride 0.05 % MouthwashSY2
1251788cetylpyridinium chloride 0.05 % Mucous Membrane Topical SolutionSY2

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
53462-561-602022-01-28C16284748780-1d6a99b39-9ce2-a426-e053-dadaa90af4c2Suction Toothbrush with Corinz® Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-375-60Suction Toothbrush with Corinz Oral Rinse7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL2
53462-561-60Suction Toothbrush with Corinz Oral Rinse1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-375SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20180403_a2a9a88e-3a51-479d-b867-dd1d1355dc88.zip
53462-561SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]2Legacy NDC, 2 package rows20180403_a2a9a88e-3a51-479d-b867-dd1d1355dc88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-56153462-561-60
53462-37553462-375-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 207T1F30V5YHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SODIUM BICARBONATE8MDF5V39QOINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
SODIUM LAURYL SULFATE368GB5141JINGR
SODIUM BENZOATEOJ245FE5EUINGR
WATER059QF0KO0RINGR
SACCHARIN SODIUMSB8ZUX40TYINGR

Source Document#

Source XML

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
ndc (package): 53462-375-60
ndc (product): 53462-375
ndc11 (package): 53462037560
68f42634-c1e0-181f-e053-2991aa0ac963a2a9a88e-3a51-479d-b867-dd1d1355dc882018-04-03WarningsExact identifier
spl id: 68f42634-c1e0-181f-e053-2991aa0ac963
spl set id: a2a9a88e-3a51-479d-b867-dd1d1355dc88

Reported adverse events (FAERS/openFDA)#

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