FDA.reportPublic FDA data

Fluoride Mouth Rinse Anticavity

Product NDC
11673-213
11-digit product format
116730213
Labeler code
11673
Product ID
11673-213_58b72a90-439e-d708-e063-6394a90aaef0
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Target Corporation
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-17
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage11673-21311673-213-77DDiscontinued by firm2026-10-15

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
Fluoride Mouth Rinse Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3daf3cc3-585a-4bb2-9b56-7117d220ed38Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-213-44Fluoride Mouth Rinse Anticavity532 mL in 1 BOTTLE, PLASTICMOUTHWASH53217
11673-213-77Fluoride Mouth Rinse Anticavity500 mL in 1 BOTTLE, PLASTICMOUTHWASH50017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
SORBITOLINACTIVE INGREDIENT506T60A25RFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2
waterINACTIVE INGREDIENT059QF0KO0RFLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-213FLUORIDE MOUTH RINSE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [TARGET CORP.]16Current NDC, Legacy NDC, 2 package rows20250409_3daf3cc3-585a-4bb2-9b56-7117d220ed38.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3daf3cc3-585a-4bb2-9b56-7117d220ed3817
240698sodium fluoride 0.5 MG/ML MouthwashSCD3daf3cc3-585a-4bb2-9b56-7117d220ed3817
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3daf3cc3-585a-4bb2-9b56-7117d220ed3817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-213-4411673021344532 mL in 1 BOTTLE, PLASTIC (11673-213-44) 532 ml2010-08-170000-00-00NoNoCurrent
11673-213-7711673021377500 mL in 1 BOTTLE, PLASTIC500 mlHistorical