FDA.reportPublic FDA data

ReddyPort Antiplaque Solution

Manufacturer
SMD Manufacturing | Elba, Inc.
Effective date
2021-01-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:48

Label at a glance#

ProductReddyPort Antiseptic Oral Rinse
Active ingredientHYDROGEN PEROXIDE, CETYLPYRIDINIUM CHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reddyport Q4 Maintenance Kit ArtworkReddyport Q4 Maintenance Kit Artwork

DOSAGE & ADMINISTRATION SECTION

Antiseptic LabelingAntiseptic Labeling

DOSAGE & ADMINISTRATION SECTION

anti-plaque outer labelinganti-plaque outer labeling

WARNINGS SECTION

Anti-plaque outer labelingAnti-plaque outer labeling

WARNINGS SECTION

Antiseptic Outer LabelingAntiseptic Outer Labeling

INDICATIONS & USAGE SECTION

Antiplaque indicationsAntiplaque indications

INDICATIONS & USAGE SECTION

antiseptic indicationsantiseptic indications

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Antiplaque OTC childrenAntiplaque OTC children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Antiseptic OTC ChildrenAntiseptic OTC Children

OTC - PURPOSE SECTION

Antiplaque PurposeAntiplaque Purpose

OTC - PURPOSE SECTION

antiseptic purposeantiseptic purpose

OTC - ACTIVE INGREDIENT SECTION

Antiplaque Active IngredientAntiplaque Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Antiseptic ActiveAntiseptic Active

INACTIVE INGREDIENT SECTION

Anti-plaque ingredientsAnti-plaque ingredients

INACTIVE INGREDIENT SECTION

antiseptic ingredientantiseptic ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReddyPort Antiplaque Solution ArtworkReddyPort Antiplaque Solution Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReddyPort Antiseptic Oral RinseReddyPort Antiseptic Oral Rinse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN2
358975hydrogen peroxide 1.5 % MouthwashPSN2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD2
358975hydrogen peroxide 15 MG/ML MouthwashSCD2
1251617cetylpyridinium chloride 0.05 % MouthwashSY2
358975hydrogen peroxide 1.5 % MouthwashSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73573-005-152023-01-30C16284748780-1f386c64a-27f2-0266-e053-dadaa90a7c1a9cbe6206-88b6-f8ab-e053-2a95a90ae497
73573-015-152023-01-30C16284748780-1f386c64a-27f2-0266-e053-dadaa90a7c1a9cbe6206-88b6-f8ab-e053-2a95a90ae497
73573-155-142023-01-30C16284748780-1f386c64a-27f2-0266-e053-dadaa90a7c1a9cbe6206-88b6-f8ab-e053-2a95a90ae497

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73573-005-15ReddyPort Antiplaque Solution14.8 mL in 1 CUPRINSE14.82
73573-015-15ReddyPort Antiseptic Oral Rinse14.8 mL in 1 CUPMOUTHWASH14.82
73573-155-14ReddyPort NIV Maintenance Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73573-005REDDYPORT ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) MOUTHWASH REDDYPORT ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) RINSE REDDYPORT NIV MAINTENANCE KIT (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SMD MANUFACTURING]2Legacy NDC, 1 package rows20210421_9cbe6206-88b6-f8ab-e053-2a95a90ae497.zip
73573-015REDDYPORT ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) MOUTHWASH REDDYPORT ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) RINSE REDDYPORT NIV MAINTENANCE KIT (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SMD MANUFACTURING]2Legacy NDC, 1 package rows20210421_9cbe6206-88b6-f8ab-e053-2a95a90ae497.zip
73573-155REDDYPORT ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) MOUTHWASH REDDYPORT ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) RINSE REDDYPORT NIV MAINTENANCE KIT (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SMD MANUFACTURING]2Legacy NDC, 1 package rows20210421_9cbe6206-88b6-f8ab-e053-2a95a90ae497.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73573-00573573-005-15
73573-01573573-015-15
73573-15573573-155-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
D&C GREEN NO. 58J6RDU8L9XIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SPEARMINTJ7I2T6IV1NIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C RED NO. 339DBA0SBB0LIACT
SORBITOL506T60A25RIACT
SPEARMINTJ7I2T6IV1NIACT
SPEARMINTJ7I2T6IV1NIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C GREEN NO. 58J6RDU8L9XIACT
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
GLYCERINPDC6A3C0OXIACT
D&C RED NO. 339DBA0SBB0LIACT
SPEARMINTJ7I2T6IV1NIACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SORBITOL506T60A25RIACT
D&C GREEN NO. 58J6RDU8L9XIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5aadaeb-6ed7-7d70-e053-2995a90ae7609cbe6206-88b6-f8ab-e053-2a95a90ae4972021-01-22WarningsExact identifier
spl id: b5aadaeb-6ed7-7d70-e053-2995a90ae760
spl set id: 9cbe6206-88b6-f8ab-e053-2a95a90ae497

Reported adverse events (FAERS/openFDA)#

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