FDA.reportPublic FDA data

Dubai Chocolate Fluoride Mouthwash

Product NDC
83729-120
11-digit product format
837290120
Labeler code
83729
Product ID
83729-120_e0865784-8b91-4590-b059-094b61530ff6
Type
HUMAN OTC DRUG
Nonproprietary name
Anticavity Mouthwash
Dosage form
LIQUID
Route
DENTAL
Labeler
SuperMouth, LLC.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-17
Substance
SODIUM FLUORIDE
Active strength
.002 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dubai Chocolate Fluoride Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.002 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef81a983-64c1-4913-9235-25451f023852Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83729-120-16Dubai Chocolate Fluoride Mouthwash473 mL in 1 BOTTLELIQUID4731

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 36 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
application number: M021
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
application number: M021
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
application number: M021
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
application number: M021
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Ipana Wintergreen FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Inc.5776cc3e-4fd1-4bd7-8d82-f82508e6b8d02025-07-28WarningsExact identifier
application number: M021
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
application number: M021
Dubai Chocolate FlavorANTICAVITY TOOTHPASTESuperMouth, LLC.d1615a53-ecfc-49d1-b836-f7643b9d26602025-07-24WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
application number: M021
Dubai Chocolate Fluoride MouthwashANTICAVITY MOUTHWASHSuperMouth, LLC.ef81a983-64c1-4913-9235-25451f0238522025-07-23WarningsExact identifier
application number: M021
ndc (product): 83729-120
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.3409a749-4a1a-4950-8c21-364d1b977af72025-07-22WarningsExact identifier
application number: M021
Act Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.dc209500-2bf4-42fb-b3a1-d0fb8d63dbd82025-07-22WarningsExact identifier
application number: M021
Brush Buddies Oral Rinse Sparkle MintSODIUM FLUORIDEASHTEL STUDIOS, INCfe2c06fc-6497-4888-877f-1a88e02fad202025-07-15WarningsExact identifier
application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.1620c7fa-2af6-4462-af5d-9e122942788a2025-07-15WarningsExact identifier
application number: M021
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83729-120-1683729012016473 mL in 1 BOTTLE (83729-120-16) 473 ml2025-07-17NoNoCurrent