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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact 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