FDA.reportPublic FDA data

Hello Unicorn Splash

Product NDC
35000-687
11-digit product format
350000687
Labeler code
35000
Product ID
35000-687_5ad12666-22b6-4760-894f-8d9e96f41714
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
SODIUM FLUORIDE
Active strength
.02 g/100mL
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
Hello Unicorn Splash
Brand name suffix
unicorn splash anticavity fluoride rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.02 g/100mL

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
a1014431-7d23-aaff-6dc7-ab58683d0338Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-687-10Hello Unicorn Splashunicorn splash anticavity fluoride rinse473 mL in 1 BOTTLEMOUTHWASH4738
35000-687-12Hello Unicorn Splashunicorn splash anticavity fluoride rinse520 mL in 1 BOTTLEMOUTHWASH5208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-687HELLO UNICORN SPLASH UNICORN SPLASH ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [COLGATE-PALMOLIVE COMPANY]7Current NDC, 2 package rows20250418_a1014431-7d23-aaff-6dc7-ab58683d0338.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 48 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
application number: M021
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNa1014431-7d23-aaff-6dc7-ab58683d03388
240698sodium fluoride 0.5 MG/ML MouthwashSCDa1014431-7d23-aaff-6dc7-ab58683d03388
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYa1014431-7d23-aaff-6dc7-ab58683d03388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-687-1035000068710473 mL in 1 BOTTLE (35000-687-10) 473 ml2023-07-01NoNoCurrent
35000-687-1235000068712520 mL in 1 BOTTLE (35000-687-12) 520 ml2026-01-01NoNoCurrent