FDA.reportPublic FDA data

Dubai Chocolate Flavor

Product NDC
83729-119
11-digit product format
837290119
Labeler code
83729
Product ID
83729-119_cba5e5ce-8d8a-4ca4-819f-88d5aa8a6d54
Type
HUMAN OTC DRUG
Nonproprietary name
Anticavity Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
SuperMouth, LLC.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-17
Substance
SODIUM FLUORIDE
Active strength
2.4 mg/g
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 Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g

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
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1615a53-ecfc-49d1-b836-f7643b9d2660Available 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
83729-119-10Dubai Chocolate Flavor1 in 1 CARTONPASTE, DENTIFRICE11
83729-119-10Dubai Chocolate Flavor96 g in 1 TUBEPASTE, DENTIFRICE961

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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Brush Buddies Value 2 pack WhiteningSODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc636bf51d-9750-4305-ab4a-3483c9f0169b2025-04-30WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNd1615a53-ecfc-49d1-b836-f7643b9d26601
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDd1615a53-ecfc-49d1-b836-f7643b9d26601
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYd1615a53-ecfc-49d1-b836-f7643b9d26601
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYd1615a53-ecfc-49d1-b836-f7643b9d26601
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYd1615a53-ecfc-49d1-b836-f7643b9d26601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83729-119-10837290119101 TUBE in 1 CARTON (83729-119-10) / 96 g in 1 TUBE1 tube2025-07-17NoNoCurrent