FDA.reportPublic FDA data

Mouth Rinse

Product NDC
0363-0163
Requested package NDC
0363-0163-86
11-digit product format
003630163
Labeler code
0363
Product ID
0363-0163_4aa46dbb-3e7c-cd84-e063-6394a90ad744
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Walgreen Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-03-15
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Mouth Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038904Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eae87899-3eba-4d50-bc31-9eaf54ff9e00Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0163-862023-10-13C16284748780-1f386c649-e915-0266-e053-dadaa90a7c1aWalgreens 163.005/163AF-AG Anticavity Mouth Rinse
0363-0163-862023-01-30C16284748780-1f386c649-e915-0266-e053-dadaa90a7c1aWalgreens 163.005/163AF-AG Anticavity Mouth Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0163-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
SORBITOLINACTIVE INGREDIENT506T60A25RMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0163MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]14Current NDC, Legacy NDC, 1 package rows20240716_eae87899-3eba-4d50-bc31-9eaf54ff9e00.zip

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 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSNeae87899-3eba-4d50-bc31-9eaf54ff9e0016
1038904sodium fluoride 0.221 MG/ML MouthwashSCDeae87899-3eba-4d50-bc31-9eaf54ff9e0016
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSYeae87899-3eba-4d50-bc31-9eaf54ff9e0016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0163-86003630163861000 mL in 1 BOTTLE, PLASTIC (0363-0163-86) 1000 ml2006-03-150000-00-00NoNoCurrent