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 firm2026-10-16

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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact 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