FDA.reportPublic FDA data

Kids Flouride Rinse

Product NDC
55301-004
11-digit product format
553010004
Labeler code
55301
Product ID
55301-004_5a1e6c37-664f-5967-e063-6394a90ab6fb
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Your Military Exchanges
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-09
Substance
SODIUM FLUORIDE
Active strength
.2 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
Kids Flouride Rinse
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
5f6f4125-6264-4724-bb7e-a6e100939b41Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-004-44Kids Flouride Rinse532 mL in 1 BOTTLE, PLASTICRINSE53222

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
SORBITOLINACTIVE INGREDIENT506T60A25RKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2
waterINACTIVE INGREDIENT059QF0KO0RKIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [YOUR MILITARY EXCHANGES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-004KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [MILITARY EXCHANGES]20Current NDC, Legacy NDC, 1 package rows20250303_5f6f4125-6264-4724-bb7e-a6e100939b41.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 RinsePSN5f6f4125-6264-4724-bb7e-a6e100939b4122
240698sodium fluoride 0.5 MG/ML MouthwashSCD5f6f4125-6264-4724-bb7e-a6e100939b4122
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY5f6f4125-6264-4724-bb7e-a6e100939b4122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-004-4455301000444532 mL in 1 BOTTLE, PLASTIC (55301-004-44) 532 ml2011-02-090000-00-00NoNoCurrent