FDA.reportPublic FDA data

Maintenance Rinse

Manufacturer
Dental Alliance Holdings LLC
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:14

Label at a glance#

ProductMaintenance Rinse Grape
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervisi...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

Purpose:

OTC - PURPOSE SECTION

Anticavity

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental caries (cavities)

Warnings:

WARNINGS SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Menthol (Mint only), Natural Flavors (Mint only), Natural and Artificial Flavors (Citrus and Grape only), Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Sodium Bicarbonate, Water, Xylitol

Maintenance Mint, Citrus, and Grape enclosure labels:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61578-311-012024-01-31C16284748780-11030e365-45eb-111a-e063-dadaa90a10e2Maintenance Rinse
61578-311-022024-01-31C16284748780-11030e365-45eb-111a-e063-dadaa90a10e2Maintenance Rinse
61578-312-012024-01-31C16284748780-11030e365-45eb-111a-e063-dadaa90a10e2Maintenance Rinse
61578-313-012024-01-31C16284748780-11030e365-45eb-111a-e063-dadaa90a10e2Maintenance Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-311-01Maintenance RinseMint473 mL in 1 BOTTLE, PLASTICRINSE4732
61578-311-02Maintenance RinseMint100 mL in 1 BOTTLE, PLASTICRINSE1002
61578-312-01Maintenance RinseCitrus473 mL in 1 BOTTLE, PLASTICRINSE4732
61578-313-01Maintenance RinseGrape473 mL in 1 BOTTLE, PLASTICRINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61578-311MAINTENANCE RINSE GRAPE (ANTICARIES) RINSE MAINTENANCE RINSE MINT (ANTICARIES) RINSE MAINTENANCE RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240202_f1273510-aa83-3ef9-e053-2a95a90aea27.zip
61578-312MAINTENANCE RINSE GRAPE (ANTICARIES) RINSE MAINTENANCE RINSE MINT (ANTICARIES) RINSE MAINTENANCE RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20240202_f1273510-aa83-3ef9-e053-2a95a90aea27.zip
61578-313MAINTENANCE RINSE GRAPE (ANTICARIES) RINSE MAINTENANCE RINSE MINT (ANTICARIES) RINSE MAINTENANCE RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20240202_f1273510-aa83-3ef9-e053-2a95a90aea27.zip

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
61578-31161578-311-01, 61578-311-02
61578-31261578-312-01
61578-31361578-313-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
MENTHOLL7T10EIP3AIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
ndc (package): 61578-311-02
ndc (package): 61578-311-01
ndc (package): 61578-313-01
ndc (package): 61578-312-01
ndc (product): 61578-312
ndc (product): 61578-311
ndc (product): 61578-313
ndc11 (package): 61578031102
ndc11 (package): 61578031101
ndc11 (package): 61578031201
ndc11 (package): 61578031301
spl id: 1046e99b-bf50-ae6f-e063-6294a90a11f6
spl set id: f1273510-aa83-3ef9-e053-2a95a90aea27

Reported adverse events (FAERS/openFDA)#

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