FDA.reportPublic FDA data

Maintenance Rinse

Product NDC
61578-312
11-digit product format
615780312
Labeler code
61578
Product ID
61578-312_1046e99b-bf50-ae6f-e063-6294a90a11f6
Type
HUMAN OTC DRUG
Nonproprietary name
Anticaries
Dosage form
RINSE
Route
DENTAL
Labeler
Dental Alliance Holdings LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
SODIUM FLUORIDE
Active strength
226 ug/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings: 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Maintenance Rinse
Brand name suffix
Citrus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE226 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-312-01Maintenance RinseCitrus473 mL in 1 BOTTLE, PLASTICRINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNf1273510-aa83-3ef9-e053-2a95a90aea272
240698sodium fluoride 0.5 MG/ML MouthwashSCDf1273510-aa83-3ef9-e053-2a95a90aea272
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYf1273510-aa83-3ef9-e053-2a95a90aea272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61578-312-0161578031201473 mL in 1 BOTTLE, PLASTIC (61578-312-01) 473 ml2022-05-100000-00-00NoNoCurrent