FDA.reportPublic FDA data

Oral Defense

Manufacturer
Oral Defense, LLC | Coastal Products Company
Effective date
2012-05-18
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 22:32:03

Label at a glance#

ProductOral Defense
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Indications and uses

Canker sores Dry mouth conditions Oral lesions from chemo and radiation therapies Diabetes Gum irritations and disease Lichen Plannus

Dosage and administration

Healthy Mouth Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue. Red, Bleeding gums and inflamed mouth For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Cetylpyridinium Chloride 0.1%

Pupose

OTC - PURPOSE SECTION

Antigingivitus/Anti-Plaque

Uses

INDICATIONS & USAGE SECTION

  • Canker sores
  • Dry mouth conditions
  • Oral lesions from chemo and radiation therapies
  • Diabetes
  • Gum irritations and disease
  • Lichen Plannus

Warnings

WARNINGS SECTION

See a dentist if symptoms or conditions persist after regular use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not swallow. In case of accidental ingestion, seek medical help or contact a poison control center immediately. Cold weather may cloud this product. Properties are not affected.

Directions

DOSAGE & ADMINISTRATION SECTION

Healthy Mouth

Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue.

Red, Bleeding gums and inflamed mouth

For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over the lesion for 1 minute, or if not possible to hold for 1 minute then use twice, 1 capful for 30 seconds each before spitting out. The most critical time of application is at bedtime, when no food or water is to be consumed after use, as the rinse has ingredients that have a long effective residual throughout the night when healing is best to occur.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, mentha piperita (peppermint oil), versene, sodium lauroyl sarcosinate, sodium hydroxide, citric acid, menthol, natamycin, FD and C green #5

Questions or comments

OTC - QUESTIONS SECTION

1-800-355-9621

Manufactured Exclusively for Oral Defense, LLC Spokane, WA 99205

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1MM1

MM2MM2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291375cetylpyridinium chloride 0.1 % MouthwashPSN17
1291375cetylpyridinium chloride 1 MG/ML MouthwashSCD17
1291375cetylpyridinium chloride 0.1 % MouthwashSY17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e89db81-98c7-14a5-4bf2-ab0ee6489391Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52644-001-002019-11-13C16284748780-197449f38-c0cb-f6ea-e053-dbdaa90aa703Oral Defense Mouth Rinse
52644-001-022019-11-13C16284748780-197449f38-c0cb-f6ea-e053-dbdaa90aa703Oral Defense Mouth Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52644-001-00Oral Defense474 mL in 1 BOTTLE, PLASTICMOUTHWASH47417
52644-001-02Oral Defense60 mL in 1 BOTTLE, PLASTICMOUTHWASH6017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52644-001ORAL DEFENSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [ORAL DEFENSE, LLC]17Legacy NDC, 2 package rows20120524_561be134-46d3-416c-becd-1d33388ddd2b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49P17
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV317
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP17
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K17
GLYCERININACTIVE INGREDIENTPDC6A3C0OX17
MENTHOLINACTIVE INGREDIENTL7T10EIP3A17
NATAMYCININACTIVE INGREDIENT8O0C852CPO17
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH17
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M217
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H17
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V317
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I17
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS9961817
SORBITOLINACTIVE INGREDIENT506T60A25R17
WATERINACTIVE INGREDIENT059QF0KO0R17

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52644-00152644-001-00, 52644-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
POLOXAMER 407TUF2IVW3M2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
NATAMYCIN8O0C852CPOIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PEPPERMINT OILAV092KU4JHIACT
MENTHOLL7T10EIP3AIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 12 · 713 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
5acd8ebf-2b8e-40d6-a76d-7bad43ff0658561be134-46d3-416c-becd-1d33388ddd2b2012-05-18WarningsExact identifier
spl id: 5acd8ebf-2b8e-40d6-a76d-7bad43ff0658
spl set id: 561be134-46d3-416c-becd-1d33388ddd2b

Reported adverse events (FAERS/openFDA)#

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