FDA.reportPublic FDA data

MySweetSmile Strawberry Toothpaste.

Product NDC
83778-092
11-digit product format
837780092
Labeler code
83778
Product ID
83778-092_5765dc83-9db2-8bec-e063-6394a90a4b41
Type
HUMAN OTC DRUG
Nonproprietary name
MySweetSmile Strawberry Toothpaste.
Dosage form
PASTE
Route
TOPICAL
Labeler
Jiangxi Dentalbright Technology Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
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 Strawberry 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
478cf338-2c98-2770-e063-6294a90a1376Available 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
83778-092-04MySweetSmile Strawberry 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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MySweetSmile Strawberry Toothpaste.MYSWEETSMILE STRAWBERRY TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cf338-2c98-2770-e063-6294a90a13762026-07-24WarningsExact identifier
ndc (product): 83778-092

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN478cf338-2c98-2770-e063-6294a90a13761
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD478cf338-2c98-2770-e063-6294a90a13761
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY478cf338-2c98-2770-e063-6294a90a13761
1044547sodium fluoride 0.25 % ToothpasteSY478cf338-2c98-2770-e063-6294a90a13761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83778-092-048377800920460 g in 1 BOTTLE (83778-092-04) 60 g2025-10-01NoNoCurrent