FDA.reportPublic FDA data

Anticavity

Product NDC
11822-6877
Requested package NDC
11822-6877-8
11-digit product format
118226877
Labeler code
11822
Product ID
11822-6877_e8cbdb78-3fbf-49db-9e6f-c0206290f3e7
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Rite Aid
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-04
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-687711822-6877-8DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6877ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [RITE AID]10Legacy NDC20240926_87356f76-4f5c-4834-9ad3-2e49bc227129.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-6877-8118226877081000 mL in 1 BOTTLE, PLASTIC (11822-6877-8) 1000 ml2017-12-040000-00-00NoNoCurrent