FDA.reportPublic FDA data

Anticavity

Product NDC
0363-0171
Requested package NDC
0363-0171-86
11-digit product format
003630171
Labeler code
0363
Product ID
0363-0171_0bd4b57a-4c95-4cb7-9842-5d7d1c0d84b2
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Walgreens
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-11
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 packagepackage0363-01710363-0171-86DDiscontinued by firm2026-10-05

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0171-86Anticavity1000 mL in 1 BOTTLE, PLASTICRINSE100012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0171ANTICAVITY (SODIUM FLUORIDE) RINSE [WALGREENS]11Legacy NDC, 1 package rows20250322_3c5039eb-b91b-440b-b7b9-d6f142c429fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN3c5039eb-b91b-440b-b7b9-d6f142c429fc12
313029sodium fluoride 0.2 MG/ML MouthwashSCD3c5039eb-b91b-440b-b7b9-d6f142c429fc12
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY3c5039eb-b91b-440b-b7b9-d6f142c429fc12
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY3c5039eb-b91b-440b-b7b9-d6f142c429fc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0171-86003630171861000 mL in 1 BOTTLE, PLASTIC (0363-0171-86) 1000 ml2020-08-110000-00-00NoNoCurrent