FDA.reportPublic FDA data

Corinz®

Manufacturer
Sage Products, LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
monthly-update
Hydrated at
2026-07-17 21:37:13

Label at a glance#

ProductCorinz
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Dosage and administration

Use up to 4 times 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 dentist or doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Purpose
CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE:
Cetylpyridinium chloride 0.05%Antiseptic Rinse

Use

OTC - WHEN USING SECTION

Helps reduce chance of infection in minor oral irritation.

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 times 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 dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

800-323-2220.

SPL UNCLASSIFIED SECTION

NOT MADE WITH NATURAL RUBBER LATEX • MADE IN U.S.A.

Corinz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R5439B_Burst PouchR5439B_Burst PouchR62128 Corinz Cup LabelingR62128 Corinz Cup LabelingCorinz Bottle LabelCorinz Bottle Label

FDA-Initiated Inactive NDC Indexing#

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-37553462-375-60, 53462-375-07, 53462-375-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162025-12-08full-release2026-06-01 01:21:19

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 · 1 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 (package): 53462-375-30
ndc (package): 53462-375-07
ndc (product): 53462-375
ndc11 (package): 53462037530
ndc11 (package): 53462037507
ndc11 (package): 53462037560
spl id: 5568e55e-72ac-77a0-e063-6294a90a0273
spl set id: 685b6023-89c4-417e-af2d-52e831855da1

Reported adverse events (FAERS/openFDA)#

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