FDA.reportPublic FDA data

Anticavity Rinse

Product NDC
63941-904
11-digit product format
639410904
Labeler code
63941
Product ID
63941-904_bfd7d2c6-24cf-4a0e-9a90-b3bab0c6d53b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Value Merchandisers, CO
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-07-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63941-904DDiscontinued by firm2026-11-10
excluded packagepackage63941-90463941-904-77DDiscontinued by firm2026-11-10

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-904-77Anticavity Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-904ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [VALUE MERCHANDISERS, CO]16Legacy NDC, 1 package rows20240123_088b95e6-30fd-4263-9fdc-57cd63385b71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN088b95e6-30fd-4263-9fdc-57cd63385b7118
240698sodium fluoride 0.5 MG/ML MouthwashSCD088b95e6-30fd-4263-9fdc-57cd63385b7118
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY088b95e6-30fd-4263-9fdc-57cd63385b7118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-904-7763941090477500 mL in 1 BOTTLE, PLASTIC (63941-904-77) 500 ml2022-07-290000-00-00NoNoCurrent