MySweetSmile Toothpaste.

Product NDC
83778-090
11-digit product format
837780090
Labeler code
83778
Product ID
83778-090_478ba92a-9cff-0f79-e063-6394a90aa72a
Type
HUMAN OTC DRUG
Nonproprietary name
MySweetSmile Toothpaste.
Dosage form
PASTE
Route
TOPICAL
Labeler
Jiangxi Dentalbright Technology Co., Ltd
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
Substance
SODIUM FLUORIDE
Active strength
.25 g/100g
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
MySweetSmile Toothpaste.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.25 g/100g

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
1044547Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
478baf87-9276-7288-e063-6294a90a9e8eAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-090-02MySweetSmile Toothpaste.60 g in 1 BOTTLEPASTE601

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 30 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzo-JelBENZOCAINEHenry Schein Inc.bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.fb38b10d-0faf-403c-9921-d4f6b0f6aa552025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.a9dc2245-c029-4453-bfc5-8fb899873c342025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.ba49a18d-8568-421b-a495-8fee863c97572025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.c9b584d9-7407-445a-b084-926250af9f8e2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.4aa6eec8-394a-4ecb-8173-66561fd649132025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.25c99ae3-90f4-4a63-924d-f810b3ba6e602025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.84e8d5c8-2a35-4179-9a9c-9a4a52c2cae62025-01-03WarningsExact identifier
application number: M022
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
application number: M022
Prevention Mouth Sore RinseHYDROGEN PEROXIDEPrevention Health Sciences, Inc.2eae61e4-1800-5fa6-e063-6394a90a95832025-01-01WarningsExact identifier
application number: M022
Antiseptic Lil Drug Store ProductsEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLLil' Drug Store Products, Incdca36a30-2c9f-4d0b-be88-b45c7046f5092024-12-31WarningsExact identifier
application number: M022
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
application number: M022
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
application number: M022
Breezers Cool BerryPECTINMondelez Global LLCb31d0078-21d7-4d18-a8d3-7c8d48d6d0042024-12-20WarningsExact identifier
application number: M022
Breezers Creamy StrawberryPECTINMondelez Global LLC777fd6db-f129-4489-8312-4b1aca94878e2024-12-20WarningsExact identifier
application number: M022
Halls Breezers Sugar Free Cool BerryPECTINMondelez Global LLCdd1b4b17-4f73-4052-9589-d5fd6bb059bb2024-12-20WarningsExact identifier
application number: M022
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
application number: M022
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN478baf87-9276-7288-e063-6294a90a9e8e1
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD478baf87-9276-7288-e063-6294a90a9e8e1
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY478baf87-9276-7288-e063-6294a90a9e8e1
1044547sodium fluoride 0.25 % ToothpasteSY478baf87-9276-7288-e063-6294a90a9e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83778-090-028377800900260 g in 1 BOTTLE (83778-090-02) 60 g2025-10-01NoNoCurrent