FDA.reportPublic FDA data

Anticavity

Product NDC
55301-163
11-digit product format
553010163
Labeler code
55301
Product ID
55301-163_5de45395-4fa4-56a7-e063-6394a90aeb6e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Your Military Exchanges
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-01-29
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
Anticavity
Listing expiration
2027-12-31

Active Ingredients#

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

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
55301-163-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-163ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [YOUR MILITARY EXCHANGES]13Current NDC, Legacy NDC, 1 package rows20240918_581d5cdb-018a-42ad-899d-5331f0063376.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 39 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2ba2318e-7a58-7b68-e063-6394a90ae7842025-03-13WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint Anticavity FluorideSODIUM FLUORIDEKenvue Brands LLCed15e0b9-00c9-0df1-e053-2a95a90a42c02025-02-28WarningsExact identifier
application number: M021
WHITE GLO BIO-ENZYMESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCf894a841-0df7-470d-8fc2-c9d6ba0edf992025-02-26WarningsExact identifier
application number: M021
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
application number: M021
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSN581d5cdb-018a-42ad-899d-5331f006337615
1038904sodium fluoride 0.221 MG/ML MouthwashSCD581d5cdb-018a-42ad-899d-5331f006337615
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSY581d5cdb-018a-42ad-899d-5331f006337615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-163-86553010163861000 mL in 1 BOTTLE, PLASTIC (55301-163-86) 1000 ml2006-01-290000-00-00NoNoCurrent