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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.ef63e193-5804-4b35-bae7-cad29cf4e8bc2026-01-12WarningsExact identifier
application number: M021
Prime Tooth Care BlueberrySODIUM FLUORIDEPrime Tooth Care LLC86642110-4572-4b8b-88f1-8d25fe05701e2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Juicy PeachSODIUM FLUORIDEPrime Tooth Care LLC142f1610-3494-459f-a956-760e82169b872026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Coconut WhipSODIUM FLUORIDEPrime Tooth Care LLC55e95657-9415-4d9c-ac9b-d021aa14e64d2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Hami MelonSODIUM FLUORIDEPrime Tooth Care LLC0028f88d-a9fe-4cfa-a6c6-168f9689b5f62026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
application number: M021
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Enamel ProtectSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf32d5708-8cb1-6499-e053-2995a90ac6322026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Complete Care Anticavity FluorideSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3a644c0-da04-276d-e053-2a95a90abf272026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon ExpressionsSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company961295a6-79ae-44b1-e053-2995a90a61302026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
application number: M021
Crest 3D White CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Express WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2d5aa-b0e6-7068-e053-2995a90ae90c2026-01-08WarningsExact 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